CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 05414734509800, Serial Numbers: P150800220, P150800221, P150800222, P150800224, P150800226, P150800227, P150800228, P150800240, P150800241, P150800242, P150800243, P150800244, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800272, P150800273, P150800274, P150800276, P150800277, P150800278, P150900312, P150900313, P150900318, P150900319, P150900321, P150900322, P150900324, P150900325, P150900326, P150900327, P150900328, P150900329, P150900331, P150900332, P150900334, P150900335, P150900336, P150900337, P150900338, P150900339, P150900341, P150900342, P150900343, P150900344, P150900346, P150900349, P150900350, P160100404, P160100405, P160100406, P160100407, P160100408, P160100410, P160100411, P160100412, P160100413, P160100414, P160100415, P160100416, P160100418, P160100419, P160100420, P160100421, P160200423, P160200425, P160200428, P160200429, P160200430, P160200431, 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P170303169, P170303170, P170303171, P170303173, P170303174, P170303175, P170303176, P170303177, P170303178, P170303179, P170303180, P170303181, P170303182, P170303183, P170303184, P170303185, P170303187, P170303188, P170303189, P170303191, P170303192, P170303193, P170303194, P170303195, P170303196, P170303198, P170303199, P170303200, P170303201, P170303202, P170303203, P170303204, P170303205, P170303206, P170303207, P170303208, P170303209, P170303210, P170303211, P170303212, P170303215, P170303216, P170303217, P170303218, P170303219, P170303220, P170303221, P170303222, P170303223, P170303224, P170303225, P170303227, P170303228, P170303229, P170303230, P170303231, P170303232, P170303233, P170303234, P170303235, P170303236, P170303237, P170303238, P170303239, P170303240, P170303241, P170303242, P170303243, P170303244, P170303245, P170303246, P170303247, P170303248, P170303249, P170303250, P170303251, P170303253, P170303254, P170303255, P170303256, P170303257, P170303258, P170303259, 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P170303355, P170303356, P170303358, P170303359, P170303360, P170303361, P170303362, P170303363, P170303364, P170303365, P170303366, P170303367, P170303370, P170303371, P170303372, P170303373, P170303374, P170303376, P170303377, P170303379, P170303380, P170303381, P170303382, P170303383, P170303384, P170303385, P170303386, P170303387, P170303388, P170303389, P170303391, P170303392, P170303393, P170303394, P170303395, P170303396, P170303397, P170303398, P170303399, P170303400, P170303401, P170303402, P170303403, P170303404, P170303405, P170303406, P170303407, P170303408, P170303409, P170303410, P170303411, P170303412, P170303413, P170303414, P170303415, P170303417, P170303418, P170303419, P170303420, P170303421, P170303423, P170303424, P170303425, P170303426, P170303427, P170303428, P170303429, P170303430, P170303431, P170303432, P170303433, P170303434, P170303435, P170303436, P170303437, P170303438, P170303440, P170303441, P170303442, P170303443, P170303444, P170303445, P170303446, P170303447, P170303448, P170303449, P170403450, P170403451, P170403452, P170403453, P170403454, P170403455, P170403456, P170403457, P170403458, P170403459, P170403460, P170403461, P170403463, P170403464, P170403465, P170403466, P170403467, P170403468, P170403469, P170403470, P170403471, P170403472, P170403473, P170403475, P170403476, P170403478, P170403479, P170403480, P170403481, P170403482, P170403483, P170403484, P170403485, P170403487, P170403488, P170403489, P170403490, P170403492, P170403493, P170403494, P170403495, P170403496, P170403497, P170403499, P170403501, P170403502, P170403503, P170403504, P170403505, P170403506, P170403507, P170403508, P170403509, P170403511, P170403512, P170403513, P170403514, P170403515, P170403516, P170403517, P170403520, P170403521, P170403522, P170403523, P170403524, P170403526, P170403527, P170403529, P170403535, P170403540, P170403543, P170403544, P170403545, P170403553, P170403554, P170403555, P170403556, P170403557, P170403558, P170403559, P170403560, P170403561, P170403562, P170403563, P170403564, P170403565, P170403566, P170403567, P170403568, P170403569, P170403571, P170403572, P170403573, P170403574, P170403575, P170403576, P170403577, P170403578, P170403579, P170403580, P170403581, P170403582, P170403584, P170403585, P170403586, P170403587, P170403588, P170403589, P170403590, P170403591, P170403592, P170403593, P170403594, P170403595, P170403596, P170403597, P170403598, P170403599, P170403600, P170403601, P170403602, P170403603, P170403604, P170403606, P170403607, P170403608, P170403609, P170403611, P170403612, P170403613, P170403614, P170403615, P170403616, P170403617, P170403619, P170403620, P170403621, P170403623, P170403624, P170403625, P170403626, P170403627, P170403628, P170403629, P170403630, P170403631, P170403632, P170403633, P170403634, P170403635, P170403636, P170403638, P170403639, P170403640, P170403641, P170403642, P170403644, P170403645, P170403647, P170403648, P170403649, P170403652, P170403656, P170403657, P170403658, P170403659, P170403660, P170403661, P170403662, P170403663, P170403664, P170403665, P170403666, P170403667, P170403668, P170403669, P170403670, P170403671, P170403672, P170403673, P170403674, P170403675, P170403677, P170403678, P170403680, P170403681, P170403682, P170403683, P170403684, P170403685, P170403686, P170403687, P170403688, P170403689, P170403690, P170403691, P170403692, P170403693, P170403694, P170403695, P170403696, P170403697, P170403698, P170403699, P170403700, P170403701, P170403702, P170403703, P170403704, P170403706, P170403707, P170403708, P170403709, P170403710, P170403711, P170403712, P170403713, P170403714, P170403715, P170403716, P170403717, P170403718, P170403719, P170403720, P170403721, P170403722, P1704
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St. Jude Medical
- Reason for Recall:
- Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
Product Codes/Lot Numbers:
UDI/DI 05414734509800, Serial Numbers: P150800220, P150800221, P150800222, P150800224, P150800226, P150800227, P150800228, P150800240, P150800241, P150800242, P150800243, P150800244, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800272, P150800273, P150800274, P150800276, P150800277, P150800278, P150900312, P150900313, P150900318, P150900319, P150900321, P150900322, P150900324, P150900325, P150900326, P150900327, P150900328, P150900329, P150900331, P150900332, P150900334, P150900335, P150900336, P150900337, P150900338, P150900339, P150900341, P150900342, P150900343, P150900344, P150900346, P150900349, P150900350, P160100404, P160100405, P160100406, P160100407, P160100408, P160100410, P160100411, P160100412, P160100413, P160100414, P160100415, P160100416, P160100418, P160100419, P160100420, P160100421, P160200423, P160200425, P160200428, P160200429, P160200430, P160200431, P160200432, P160200434, P160200435, P160200436, P160200437, P160200438, P160200439, P160200440, P160200441, P160200442, P160200445, P160200448, P160200449, P160200450, P160200451, P160200452, P160200453, P160200456, P160200457, P160200458, P160200459, P160200460, P160200464, P160200465, P160200466, P160200469, P160200470, P160200473, P160200475, P160200476, P160200479, P160200481, P160200483, P160200484, P160200485, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200494, P160200495, P160200496, P160200497, P160200498, P160200499, P160200500, P160200502, P160200503, P160200504, P160200505, P160200507, P160200508, P160200509, P160200510, P160200511, P160200512, P160200513, P160200514, P160200515, P160200516, P160200517, P160200518, P160200519, P160200520, P160200521, P160200522, P160200523, P160200524, P160200525, P160200526, P160200527, P160200528, P160200529, P160200530, P160200531, P160200532, P160200533, P160200534, P160200535, P160200536, P160200537, P160200538, P160200539, P160200540, 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P161101500, P161101502, P161101503, P161101504, P161101505, P161101506, P161101508, P161101509, P161101510, P161101511, P161101512, P161101513, P161101514, P161101515, P161101516, P161101517, P161101519, P161101520, P161101521, P161101522, P161101523, P161101524, P161101525, P161101526, P161101527, P161101528, P161101529, P161101530, P161101531, P161101532, P161101533, P161101534, P161101535, P161101536, P161101537, P161101538, P161101539, P161101540, P161101541, P161101542, P161101543, P161101544, P161101545, P161101546, P161101547, P161101548, P161101551, P161101552, P161101553, P161101554, P161101555, P161101556, P161101557, P161101558, P161101559, P161101560, P161101561, P161101562, P161101563, P161101564, P161101567, P161101568, P161101569, P161101570, P161101571, P161101572, P161201573, P161201574, P161201575, P161201576, P161201577, P161201578, P161201581, P161201583, P161201584, P161201585, P161201586, P161201589, P161201593, P161201594, P161201595, P161201597, P161201598, P161201599, P161201600, P161201601, P161201602, P161201603, P161201606, P161201608, P161201609, P161201610, P161201611, P161201613, P161201614, P161201615, P161201616, P161201617, P161201618, P161201619, P161201620, P161201621, P161201622, P161201623, P161201624, P161201626, P161201627, P161201628, P161201629, P161201631, P161201633, P161201634, P161201635, P161201636, P161201638, P161201640, P161201641, P161201642, P161201643, P161201644, P161201645, P161201646, P161201647, P161201648, P161201649, P161201650, P161201651, P161201653, P161201654, P161201655, P161201656, P161201657, P161201658, P161201659, P161201660, P161201661, P161201662, P161201697, P161201698, P161201699, P161201700, P161201701, P161201702, P161201703, P161201704, P161201705, P161201706, P161201707, P161201708, P161201709, P161201710, P161201711, P161201712, P161201713, P161201715, P161201716, P161201717, P161201718, P161201719, P161201720, P161201721, P161201722, P161201723, P161201724, P161201725, P161201726, P161201733, P161201734, P161201735, P161201736, P161201737, P161201739, P161201740, P161201741, P161201742, P161201743, P161201744, P161201745, P161201746, P161201748, P161201749, P161201750, P161201751, P161201752, P161201757, P161201759, P161201762, P161201764, P161201765, P161201766, P161201767, P161201770, P161201776, P161201777, P161201778, P161201780, P161201782, P161201783, P161201784, P161201785, P161201786, P161201787, P161201788, P161201789, P161201790, P161201791, P161201792, P161201793, P161201794, P161201795, P161201796, P170101817, P170101818, P170101819, P170101820, P170101821, P170101822, P170101824, P170101825, P170101826, P170101827, P170101828, P170101829, P170101830, P170101831, P170101832, P170101833, P170101835, P170101837, P170101838, P170101839, P170101840, P170101841, P170101843, P170101845, P170101846, P170101847, P170101848, P170101851, P170101852, P170101853, P170101854, P170101855, P170101857, P170101858, P170101859, P170101860, P170101861, P170101862, P170101863, P170101864, P170101865, P170101866, P170101867, P170101868, P170101869, P170101870, P170101872, P170101873, P170101874, P170101875, P170101876, P170101877, P170101879, P170101880, P170101881, P170101882, P170101883, P170101884, P170101885, P170101886, P170101887, P170101888, P170101889, P170101891, P170101892, P170101893, P170101894, P170101896, P170101897, P170101898, P170101908, P170101910, P170101911, P170101912, P170101913, P170101914, P170101915, P170101916, P170101917, P170101918, P170101919, P170101920, P170101921, P170101923, P170101924, P170101925, P170101926, P170101928, P170101929, P170101930, P170101931, P170101932, P170101933, P170101934, P170101935, P170101936, P170101937, P170101954, P170101955, P170101956, P170101960, P170101961, P170101962, P170101963, P170101964, P170101965, P170101966, P170101967, P170101968, P170101970, P170101971, P170101972, P170101973, P170101974, P170101975, P170101976, P170101977, P170101978, P170101979, P170101980, P170101982, P170101983, P170101985, P170101986, P170101987, P170101988, P170101989, P170101990, P170101991, P170101992, P170101993, P170101994, P170101995, P170101996, P170101997, P170101998, P170101999, P170102000, P170102001, P170102002, P170102003, P170102004, P170102005, P170102006, P170102007, P170102008, P170102009, P170102010, P170102011, P170102012, P170102014, P170102015, P170102016, P170102017, P170102019, P170102020, P170102024, P170102031, P170102032, P170102038, P170102042, P170102045, P170102048, P170102049, P170102050, P170102051, P170102053, P170102054, P170102055, P170102056, P170102057, P170102058, P170102061, P170102062, P170102064, P170102066, P170102067, P170102068, P170102069, P170102071, P170102072, P170102073, P170102074, P170102075, P170102076, P170102077, P170102078, P170102079, P170102080, P170102082, P170102084, P170102085, P170102086, P170102088, P170102090, P170102091, P170102092, P170102093, P170102094, P170102096, P170102097, P170102098, P170102099, P170102100, P170102101, P170102102, P170102103, P170102104, P170102105, P170102106, P170102107, P170102108, P170102109, P170102110, P170102111, P170102112, P170102113, P170102114, P170102115, P170102116, P170102117, P170102118, P170102119, P170102120, P170102121, P170102122, P170102123, P170102124, P170102125, P170102126, P170102127, P170102128, P170102129, P170102130, P170102134, P170102136, P170102138, P170102139, P170102140, P170102141, P170102142, P170102143, P170102144, P170102145, P170102146, P170102147, P170102148, P170102149, P170102150, P170102151, P170102152, P170102153, P170102154, P170102156, P170102157, P170102158, P170102159, P170102160, P170102161, P170102162, P170102163, P170102164, P170102165, P170102167, P170102170, P170102171, P170102172, P170102173, P170102174, P170102175, P170102176, P170102177, P170102178, P170102179, P170102180, P170102181, P170102182, P170102183, P170102184, P170102185, P170102186, P170102187, P170102189, P170102190, P170102191, P170102192, P170102193, P170102194, P170102195, P170102196, P170102197, P170102199, P170102200, P170102201, P170102202, P170102203, P170102204, P170102205, P170102206, P170102207, P170102208, P170102209, P170102210, P170102211, P170102212, P170102213, P170102214, P170102215, P170102216, P170102217, P170102218, P170102219, P170102221, P170102222, P170102223, P170102224, P170102225, P170102226, P170102227, P170102228, P170102229, P170102230, P170102231, P170102232, P170102233, P170102234, P170102235, P170102236, P170102237, P170102238, P170102239, P170102243, P170102245, P170102247, P170102259, P170102260, P170102261, P170102262, P170102263, P170102264, P170102265, P170102266, P170102268, P170102269, P170102270, P170102271, P170102272, P170102273, P170102274, P170102275, P170102276, P170102278, P170102279, P170102280, P170102281, P170102282, P170102283, P170102284, P170102285, P170102286, P170102287, P170102288, P170102289, P170102290, P170102291, P170102292, P170102293, P170102294, P170102295, P170102296, P170102297, P170102299, P170202300, P170202301, P170202303, P170202304, P170202305, P170202306, P170202307, P170202309, P170202311, P170202312, P170202313, P170202314, P170202315, P170202316, P170202318, P170202319, P170202320, P170202321, P170202322, P170202324, P170202325, P170202326, P170202328, P170202329, P170202330, P170202332, P170202333, P170202335, P170202336, P170202337, P170202338, P170202339, P170202341, P170202342, P170202343, P170202344, P170202346, P170202348, P170202349, P170202350, P170202351, P170202352, P170202353, P170202354, P170202355, P170202357, P170202358, P170202359, P170202360, P170202361, P170202362, P170202363, P170202364, P170202365, P170202366, P170202367, P170202368, P170202369, P170202370, P170202371, P170202372, P170202373, P170202374, P170202375, P170202376, P170202377, P170202378, P170202379, P170202380, P170202381, P170202382, P170202383, P170202384, P170202385, P170202386, P170202388, P170202389, P170202390, P170202391, P170202393, P170202394, P170202395, P170202396, P170202397, P170202399, P170202400, P170202401, P170202402, P170202404, P170202405, P170202406, P170202407, P170202408, P170202409, P170202410, P170202411, P170202412, P170202414, P170202416, P170202418, P170202419, P170202420, P170202421, P170202422, P170202424, P170202426, P170202427, P170202428, P170202429, P170202430, P170202432, P170202433, P170202434, P170202435, P170202436, P170202438, P170202439, P170202440, P170202441, P170202442, P170202443, P170202445, P170202447, P170202448, P170202449, P170202450, P170202451, P170202452, P170202453, P170202454, P170202456, P170202458, P170202460, P170202461, P170202462, P170202463, P170202464, P170202465, P170202466, P170202467, P170202468, P170202469, P170202470, P170202471, P170202472, P170202473, P170202474, P170202475, P170202476, P170202477, P170202478, P170202479, P170202480, P170202481, P170202482, P170202483, P170202484, P170202485, P170202486, P170202487, P170202488, P170202489, P170202490, P170202491, P170202492, P170202493, P170202494, P170202496, P170202497, P170202498, P170202499, P170202501, P170202502, P170202503, P170202504, P170202507, P170202508, P170202509, P170202510, P170202511, P170202512, P170202513, P170202514, P170202515, P170202516, P170202517, P170202519, P170202522, P170202523, P170202524, P170202525, P170202527, P170202528, P170202529, P170202530, P170202531, P170202532, P170202533, P170202534, P170202535, P170202536, P170202537, P170202538, P170202539, P170202541, P170202542, P170202543, P170202544, P170202545, P170202546, P170202547, P170202548, P170202549, P170202550, P170202551, P170202552, P170202553, P170202554, P170202556, P170202557, P170202558, P170202559, P170202560, P170202561, P170202562, P170202563, P170202564, P170202565, P170202566, P170202567, P170202568, P170202570, P170202571, P170202572, P170202573, P170202574, P170202575, P170202576, P170202577, P170202578, P170202579, P170202580, P170202581, P170202582, P170202583, P170202584, P170202585, P170202586, P170202587, P170202588, P170202589, P170202590, P170202591, P170202592, P170202593, P170202594, P170202595, P170202596, P170202597, P170202598, P170202599, P170202600, P170202601, P170202602, P170202603, P170202604, P170202605, P170202606, P170202607, P170202609, P170202610, P170202611, P170202612, P170202613, P170202614, P170202615, P170202616, P170202617, P170202618, P170202619, P170202620, P170202621, P170202622, P170202623, P170202624, P170202625, P170202626, P170202627, P170202628, P170202629, P170202630, P170202631, P170202633, P170202635, P170202636, P170202637, P170202638, P170202639, P170202640, P170202641, P170202642, P170202643, P170202644, P170202645, P170202646, P170202647, P170202648, P170202649, P170202651, P170202652, P170202653, P170202654, P170202655, P170202656, P170202657, P170202658, P170202659, P170202660, P170202662, P170202663, P170202665, P170202666, P170202667, P170202668, P170202669, P170202670, P170202671, P170202672, P170202673, P170202674, P170202675, P170202676, P170202677, P170202678, P170202679, P170202680, P170202681, P170202682, P170202683, P170202684, P170202685, P170202686, P170202687, P170202688, P170202689, P170202690, P170202691, P170202692, P170202693, P170202694, P170202695, P170202696, P170202697, P170202698, P170202699, P170202700, P170202701, P170202702, P170202703, P170202704, P170202705, P170202706, P170202707, P170202708, P170202709, P170202710, P170202711, P170202712, P170202714, P170202715, P170202716, P170202719, P170202720, P170202721, P170202722, P170202723, P170202724, P170202725, P170202726, P170202727, P170202728, P170202731, P170202732, P170202733, P170202734, P170202735, P170202736, P170202737, P170202738, P170202739, P170202741, P170202742, P170202743, P170202744, P170202745, P170202746, P170202747, P170202748, P170202749, P170202750, P170202751, P170202752, P170202753, P170202754, P170202755, P170202756, P170202757, P170202758, P170202760, P170202761, P170202762, P170202763, P170202764, P170202765, P170202766, P170202767, P170202768, P170202770, P170202772, P170202773, P170202774, P170202775, P170202776, P170202779, P170202780, P170202781, P170202782, P170202784, P170202785, P170202786, P170202787, P170202788, P170202789, P170202790, P170202793, P170202794, P170202795, P170202796, P170202798, P170202800, P170202801, P170202802, P170202803, P170202804, P170202805, P170202808, P170202813, P170202816, P170202818, P170202820, P170202821, P170202822, P170202823, P170202824, P170202825, P170202826, P170202827, P170202828, P170202829, P170202830, P170202831, P170202832, P170202833, P170202834, P170202835, P170202836, P170202837, P170202838, P170202839, P170202840, P170202841, P170202843, P170202844, P170202845, P170202846, P170202847, P170202848, P170202849, P170202850, P170202851, P170202852, P170202853, P170202854, P170202855, P170202856, P170202858, P170202859, P170202861, P170202863, P170202864, P170202865, P170202869, P170202870, P170202871, P170202872, P170202873, P170202874, P170202875, P170202876, P170202877, P170202878, P170202879, P170202880, P170202883, P170202885, P170202886, P170202887, P170202888, P170202889, P170202890, P170202892, P170202893, P170202894, P170202895, P170202896, P170202897, P170202898, P170202899, P170202900, P170202901, P170202902, P170202904, P170202905, P170202906, P170202907, P170202908, P170202909, P170202910, P170202911, P170202912, P170202913, P170202914, P170202915, P170202916, P170202917, P170202918, P170202920, P170202921, P170202922, P170202923, P170202924, P170202925, P170202926, P170202927, P170202928, P170202929, P170202930, P170202931, P170202934, P170202936, P170202937, P170202938, P170202939, P170202940, P170202941, P170202942, P170202943, P170202944, P170202945, P170202946, P170202947, P170202948, P170202949, P170202950, P170202951, P170202952, P170202953, P170202954, P170202955, P170202956, P170202957, P170202958, P170202959, P170202960, P170202961, P170202962, P170202963, P170202964, P170202965, P170202966, P170202967, P170202968, P170202969, P170202970, P170202971, P170202972, P170202974, P170202975, P170202976, P170202977, P170202978, P170202979, P170202980, P170202981, P170202982, P170202983, P170202984, P170202985, P170202986, P170202987, P170202989, P170202990, P170202991, P170202992, P170202993, P170202994, P170202997, P170202998, P170202999, P170203000, P170203001, P170203002, P170203004, P170203005, P170203006, P170203007, P170203008, P170203009, P170203011, P170203012, P170203013, P170203014, P170203016, P170203017, P170203018, P170203019, P170303022, P170303024, P170303037, P170303040, P170303041, P170303042, P170303043, P170303045, P170303050, P170303051, P170303052, P170303053, P170303055, P170303056, P170303057, P170303058, P170303059, P170303060, P170303061, P170303062, P170303063, P170303065, P170303066, P170303067, P170303068, P170303069, P170303070, P170303071, P170303073, P170303074, P170303075, P170303076, P170303078, P170303079, P170303080, P170303081, P170303082, P170303083, P170303084, P170303086, P170303087, P170303088, P170303089, P170303090, P170303091, P170303092, P170303093, P170303094, P170303095, P170303097, P170303098, P170303100, P170303101, P170303102, P170303103, P170303104, P170303105, P170303106, P170303107, P170303108, P170303109, P170303110, P170303111, P170303112, P170303113, P170303114, P170303115, P170303116, P170303117, P170303118, P170303119, P170303121, P170303122, P170303123, P170303124, P170303125, P170303126, P170303128, P170303129, P170303130, P170303131, P170303132, P170303133, P170303134, P170303135, P170303136, P170303137, P170303138, P170303139, P170303140, P170303141, P170303142, P170303143, P170303144, P170303145, P170303146, P170303147, P170303148, P170303149, P170303150, P170303151, P170303153, P170303154, P170303155, P170303156, P170303157, P170303158, P170303159, P170303160, P170303161, P170303162, P170303163, P170303164, P170303165, P170303166, P170303168, P170303169, P170303170, P170303171, P170303173, P170303174, P170303175, P170303176, P170303177, P170303178, P170303179, P170303180, P170303181, P170303182, P170303183, P170303184, P170303185, P170303187, P170303188, P170303189, P170303191, P170303192, P170303193, P170303194, P170303195, P170303196, P170303198, P170303199, P170303200, P170303201, P170303202, P170303203, P170303204, P170303205, P170303206, P170303207, P170303208, P170303209, P170303210, P170303211, P170303212, P170303215, P170303216, P170303217, P170303218, P170303219, P170303220, P170303221, P170303222, P170303223, P170303224, P170303225, P170303227, P170303228, P170303229, P170303230, P170303231, P170303232, P170303233, P170303234, P170303235, P170303236, P170303237, P170303238, P170303239, P170303240, P170303241, P170303242, P170303243, P170303244, P170303245, P170303246, P170303247, P170303248, P170303249, P170303250, P170303251, P170303253, P170303254, P170303255, P170303256, P170303257, P170303258, P170303259, P170303260, P170303261, P170303262, P170303263, P170303264, P170303265, P170303266, P170303267, P170303268, P170303269, P170303270, P170303272, P170303273, P170303274, P170303275, P170303278, P170303279, P170303280, P170303281, P170303282, P170303283, P170303285, P170303286, P170303287, P170303288, P170303289, P170303290, P170303291, P170303292, P170303293, P170303294, P170303295, P170303296, P170303297, P170303298, P170303299, P170303300, P170303301, P170303302, P170303303, P170303305, P170303308, P170303309, P170303310, P170303312, P170303313, P170303314, P170303315, P170303316, P170303317, P170303318, P170303319, P170303320, P170303321, P170303322, P170303323, P170303324, P170303325, P170303326, P170303328, P170303329, P170303330, P170303331, P170303332, P170303333, P170303334, P170303335, P170303336, P170303337, P170303338, P170303339, P170303340, P170303341, P170303342, P170303343, P170303345, P170303346, P170303347, P170303349, P170303350, P170303351, P170303353, P170303354, P170303355, P170303356, P170303358, P170303359, P170303360, P170303361, P170303362, P170303363, P170303364, P170303365, P170303366, P170303367, P170303370, P170303371, P170303372, P170303373, P170303374, P170303376, P170303377, P170303379, P170303380, P170303381, P170303382, P170303383, P170303384, P170303385, P170303386, P170303387, P170303388, P170303389, P170303391, P170303392, P170303393, P170303394, P170303395, P170303396, P170303397, P170303398, P170303399, P170303400, P170303401, P170303402, P170303403, P170303404, P170303405, P170303406, P170303407, P170303408, P170303409, P170303410, P170303411, P170303412, P170303413, P170303414, P170303415, P170303417, P170303418, P170303419, P170303420, P170303421, P170303423, P170303424, P170303425, P170303426, P170303427, P170303428, P170303429, P170303430, P170303431, P170303432, P170303433, P170303434, P170303435, P170303436, P170303437, P170303438, P170303440, P170303441, P170303442, P170303443, P170303444, P170303445, P170303446, P170303447, P170303448, P170303449, P170403450, P170403451, P170403452, P170403453, P170403454, P170403455, P170403456, P170403457, P170403458, P170403459, P170403460, P170403461, P170403463, P170403464, P170403465, P170403466, P170403467, P170403468, P170403469, P170403470, P170403471, P170403472, P170403473, P170403475, P170403476, P170403478, P170403479, P170403480, P170403481, P170403482, P170403483, P170403484, P170403485, P170403487, P170403488, P170403489, P170403490, P170403492, P170403493, P170403494, P170403495, P170403496, P170403497, P170403499, P170403501, P170403502, P170403503, P170403504, P170403505, P170403506, P170403507, P170403508, P170403509, P170403511, P170403512, P170403513, P170403514, P170403515, P170403516, P170403517, P170403520, P170403521, P170403522, P170403523, P170403524, P170403526, P170403527, P170403529, P170403535, P170403540, P170403543, P170403544, P170403545, P170403553, P170403554, P170403555, P170403556, P170403557, P170403558, P170403559, P170403560, P170403561, P170403562, P170403563, P170403564, P170403565, P170403566, P170403567, P170403568, P170403569, P170403571, P170403572, P170403573, P170403574, P170403575, P170403576, P170403577, P170403578, P170403579, P170403580, P170403581, P170403582, P170403584, P170403585, P170403586, P170403587, P170403588, P170403589, P170403590, P170403591, P170403592, P170403593, P170403594, P170403595, P170403596, P170403597, P170403598, P170403599, P170403600, P170403601, P170403602, P170403603, P170403604, P170403606, P170403607, P170403608, P170403609, P170403611, P170403612, P170403613, P170403614, P170403615, P170403616, P170403617, P170403619, P170403620, P170403621, P170403623, P170403624, P170403625, P170403626, P170403627, P170403628, P170403629, P170403630, P170403631, P170403632, P170403633, P170403634, P170403635, P170403636, P170403638, P170403639, P170403640, P170403641, P170403642, P170403644, P170403645, P170403647, P170403648, P170403649, P170403652, P170403656, P170403657, P170403658, P170403659, P170403660, P170403661, P170403662, P170403663, P170403664, P170403665, P170403666, P170403667, P170403668, P170403669, P170403670, P170403671, P170403672, P170403673, P170403674, P170403675, P170403677, P170403678, P170403680, P170403681, P170403682, P170403683, P170403684, P170403685, P170403686, P170403687, P170403688, P170403689, P170403690, P170403691, P170403692, P170403693, P170403694, P170403695, P170403696, P170403697, P170403698, P170403699, P170403700, P170403701, P170403702, P170403703, P170403704, P170403706, P170403707, P170403708, P170403709, P170403710, P170403711, P170403712, P170403713, P170403714, P170403715, P170403716, P170403717, P170403718, P170403719, P170403720, P170403721, P170403722, P1704
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1220-2023
Related Recalls
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.