MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 10432915. 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Serial Numbers: 45046, 45115, 45398, 145760, 145811, 45549, 45834, 146099, 146110, 45047, 146093, 46066, 45788, 146082, 45124, 45185, 45332, 45466, 145390, 45732, 45918, 45380, 46182, 45735, 45233, 145735, 145008, 145473, 145095, 145664, 45200, 146098, 146086, 45805, 45812, 45397, 46264, 45499, 45749, 45289, 46220, 45369, 45267, 45253, 45060, 146103, 45333, 146123, 46147, 145721, 145840, 145088, 146124, 45841, 45890, 46295, 45306, 45519, 145905, 46242, 145806, 46171, 45148, 45152, 46194, 145152, 45119, 46207, 145549, 45402, 145090, 145681, 45877, 45693, 45679, 146067, 45140, 46163, 145635, 46028, 45138, 46282, 45479, 45496, 45143, 45314, 45368, 46268, 45998, 145423, 145190, 145377, 46005, 45886, 45905, 145706, 145684, 45990, 145063, 146119, 46260, 45118, 145062, 45506, 145528, 145547, 46206, 145552, 45129, 145330, 45910, 145128, 145750, 45976, 145688, 45182, 145497, 45411, 145150, 45213, 145115, 45683, 145672, 145526, 45737, 45753, 145041, 145042, 45339, 45338, 145040, 145167, 45403, 145799, 145843, 145658, 145086, 45197, 45196, 145108, 46203, 145414, 46027, 145301, 45988, 45279, 145384, 145596, 45881, 145568, 45942, 146085, 145685, 145674, 45088, 145862, 45095, 45676, 46144, 45108, 145300, 46044, 46169, 45537, 145026, 46290, 145758, 45084, 145270, 146117, 146092, 45195, 145631, 45684, 45940, 146114, 145666, 145380, 145816, 45120, 145921, 145842, 145554, 46232, 45135, 145710, 145044, 145686, 46279, 145638, 145367, 145170, 145689, 145187, 45495, 45298, 145164, 46176, 45399, 46261, 145334, 145633, 45375, 45351, 146128, 45276, 46179, 145610, 46048, 145810, 46168, 46121, 45705, 45284, 145669, 145831, 145206, 145667, 45477, 145104, 45112, 146075, 145445, 46032, 145544, 46050, 45212, 46276, 145687, 145099, 145256, 46161, 46020, 45761, 145338, 45736, 145541, 145545, 145259, 145952, 46149, 45149, 45407, 45327, 45944, 45006, 45371, 46238, 145130, 45983, 46189, 145700, 45236, 45201, 145747, 46273, 45520, 145774, 46303, 45116, 145262, 145663, 45456, 45624, 145754, 45599, 145148, 45690, 45963, 45346, 45995, 45293, 145179, 45770, 145161, 145145, 145620, 145476, 46127, 45435, 45155, 46047, 45295, 45160, 45603, 145892, 45543, 45847, 145269, 145770, 46259, 45817, 145827, 45856, 45526, 145731, 145640, 145266, 45117, 45324, 45968, 145775, 45372, 145454, 45249, 45958, 145343, 145255, 145110, 46286, 145609, 145790, 145030, 145011, 145012, 145105, 45219, 145061, 145533, 145532, 45774, 45167, 45069, 146105, 145924, 145113, 45085, 45741, 45147, 145193, 46289, 145622, 45121, 45150, 46175, 45536, 46237, 145032, 46191, 46143, 45733, 46081, 45158, 45110, 145492, 46100, 45379, 45318, 145394, 45681, 145886, 145491, 45425, 145761, 45031, 145632, 145182, 145124, 45996, 45107, 45428, 45635, 46021, 46007, 46105, 46142, 45203, 45018, 145850, 146102, 146100, 45019, 145826, 145521, 145860, 45417, 45928, 145097, 145323, 46205, 145325, 45906, 146115, 45815, 45042, 145594, 145801, 45500, 45986, 45202, 45553, 45381, 145020, 45566, 145990, 145728, 45959, 46009, 45134, 145447, 45474, 145149, 45099, 45349, 46150, 145143, 46016, 145605, 146127, 145785, 45623, 145089, 145209, 45835, 145302, 145815, 45082, 45079, 45878, 45452, 145246, 46086, 45850, 46239, 46140, 45773, 145293, 145127, 45556, 45870, 145486, 46026, 145485, 145403, 145624, 145245, 46034, 45455, 145443, 145297, 45288, 145582, 145772, 46297, 45667, 45430, 146090, 45074, 45585, 45128, 45239, 145386, 145489, 45328, 45580, 45122, 45078, 145449, 45387, 45804, 145536, 145569, 145781, 145629, 145504, 45682, 45072, 145565, 46222, 45948, 145718, 145282, 45056, 45970, 45408, 145066, 145796, 46310, 46311, 45273, 45214, 45631, 45386, 145275, 145704, 45406, 46107, 46102, 45080, 145717, 145320, 45220, 45424, 145522, 145230, 45228, 45348, 45649, 46190, 145142, 145636, 145222, 145111, 145598, 45181, 45229, 45105, 145839, 45840, 45685, 145292, 45132, 46288, 45291, 45857, 46157, 45266, 45839, 45208, 146078, 145450, 45307, 45982, 46145, 46298, 145169, 45237, 45869, 45230, 45205, 45694, 45507, 46281, 145311, 45232, 145662, 45390, 145087, 45255, 145332, 45409, 45559, 45130, 146120, 145197, 45777, 145072, 145626, 145794, 145864, 146122, 146121, 45669, 45801, 45436, 45545, 46201, 46080, 45945, 145227, 45093, 46243, 45818, 45071, 45111, 145075, 46294, 45199, 45638. Additional serial numbers added 11/14/2025: 45395, 45442, 45291.
- 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:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Product Codes/Lot Numbers:
Model Number: 10432915. 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(01)04056869006703(21)145850, (01)04056869006703(21)146102, (01)04056869006703(21)146100, (01)04056869006703(21)45019, (01)04056869006703(21)145826, (01)04056869006703(21)145521, (01)04056869006703(21)145860, (01)04056869006703(21)45417, (01)04056869006703(21)45928, (01)04056869006703(21)145097, (01)04056869006703(21)145323, (01)04056869006703(21)46205, (01)04056869006703(21)145325, (01)04056869006703(21)45906, (01)04056869006703(21)146115, (01)04056869006703(21)45815, (01)04056869006703(21)45042, (01)04056869006703(21)145594, (01)04056869006703(21)145801, (01)04056869006703(21)45500, (01)04056869006703(21)45986, (01)04056869006703(21)45202, (01)04056869006703(21)45553, (01)04056869006703(21)45381, (01)04056869006703(21)145020, (01)04056869006703(21)45566, (01)04056869006703(21)145990, (01)04056869006703(21)145728, (01)04056869006703(21)45959, (01)04056869006703(21)46009, (01)04056869006703(21)45134, (01)04056869006703(21)145447, (01)04056869006703(21)45474, 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(01)04056869006703(21)145624, (01)04056869006703(21)145245, (01)04056869006703(21)46034, (01)04056869006703(21)45455, (01)04056869006703(21)145443, (01)04056869006703(21)145297, (01)04056869006703(21)45288, (01)04056869006703(21)145582, (01)04056869006703(21)145772, (01)04056869006703(21)46297, (01)04056869006703(21)45667, (01)04056869006703(21)45430, (01)04056869006703(21)146090, (01)04056869006703(21)45074, (01)04056869006703(21)45585, (01)04056869006703(21)45128, (01)04056869006703(21)45239, (01)04056869006703(21)145386, (01)04056869006703(21)145489, (01)04056869006703(21)45328, (01)04056869006703(21)45580, (01)04056869006703(21)45122, (01)04056869006703(21)45078, (01)04056869006703(21)145449, (01)04056869006703(21)45387, (01)04056869006703(21)45804, (01)04056869006703(21)145536, (01)04056869006703(21)145569, (01)04056869006703(21)145781, (01)04056869006703(21)145629, (01)04056869006703(21)145504, (01)04056869006703(21)45682, (01)04056869006703(21)45072, (01)04056869006703(21)145565, (01)04056869006703(21)46222, (01)04056869006703(21)45948, (01)04056869006703(21)145718, (01)04056869006703(21)145282, (01)04056869006703(21)45056, (01)04056869006703(21)45970, (01)04056869006703(21)45408, (01)04056869006703(21)145066, (01)04056869006703(21)145796, (01)04056869006703(21)46310, (01)04056869006703(21)46311, (01)04056869006703(21)45273, (01)04056869006703(21)45214, (01)04056869006703(21)45631, (01)04056869006703(21)45386, (01)04056869006703(21)145275, (01)04056869006703(21)145704, (01)04056869006703(21)45406, (01)04056869006703(21)46107, (01)04056869006703(21)46102, (01)04056869006703(21)45080, (01)04056869006703(21)145717, (01)04056869006703(21)145320, (01)04056869006703(21)45220, (01)04056869006703(21)45424, (01)04056869006703(21)145522, (01)04056869006703(21)145230, (01)04056869006703(21)45228, (01)04056869006703(21)45348, (01)04056869006703(21)45649, (01)04056869006703(21)46190, (01)04056869006703(21)145142, (01)04056869006703(21)145636, (01)04056869006703(21)145222, (01)04056869006703(21)145111, (01)04056869006703(21)145598, (01)04056869006703(21)45181, (01)04056869006703(21)45229, (01)04056869006703(21)45105, (01)04056869006703(21)145839, (01)04056869006703(21)45840, (01)04056869006703(21)45685, (01)04056869006703(21)145292, (01)04056869006703(21)45132, (01)04056869006703(21)46288, (01)04056869006703(21)45291, (01)04056869006703(21)45857, (01)04056869006703(21)46157, (01)04056869006703(21)45266, (01)04056869006703(21)45839, (01)04056869006703(21)45208, (01)04056869006703(21)146078, (01)04056869006703(21)145450, (01)04056869006703(21)45307, (01)04056869006703(21)45982, (01)04056869006703(21)46145, (01)04056869006703(21)46298, (01)04056869006703(21)145169, (01)04056869006703(21)45237, (01)04056869006703(21)45869, (01)04056869006703(21)45230, (01)04056869006703(21)45205, (01)04056869006703(21)45694, (01)04056869006703(21)45507, (01)04056869006703(21)46281, (01)04056869006703(21)145311, (01)04056869006703(21)45232, 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Serial Numbers: 45046, 45115, 45398, 145760, 145811, 45549, 45834, 146099, 146110, 45047, 146093, 46066, 45788, 146082, 45124, 45185, 45332, 45466, 145390, 45732, 45918, 45380, 46182, 45735, 45233, 145735, 145008, 145473, 145095, 145664, 45200, 146098, 146086, 45805, 45812, 45397, 46264, 45499, 45749, 45289, 46220, 45369, 45267, 45253, 45060, 146103, 45333, 146123, 46147, 145721, 145840, 145088, 146124, 45841, 45890, 46295, 45306, 45519, 145905, 46242, 145806, 46171, 45148, 45152, 46194, 145152, 45119, 46207, 145549, 45402, 145090, 145681, 45877, 45693, 45679, 146067, 45140, 46163, 145635, 46028, 45138, 46282, 45479, 45496, 45143, 45314, 45368, 46268, 45998, 145423, 145190, 145377, 46005, 45886, 45905, 145706, 145684, 45990, 145063, 146119, 46260, 45118, 145062, 45506, 145528, 145547, 46206, 145552, 45129, 145330, 45910, 145128, 145750, 45976, 145688, 45182, 145497, 45411, 145150, 45213, 145115, 45683, 145672, 145526, 45737, 45753, 145041, 145042, 45339, 45338, 145040, 145167, 45403, 145799, 145843, 145658, 145086, 45197, 45196, 145108, 46203, 145414, 46027, 145301, 45988, 45279, 145384, 145596, 45881, 145568, 45942, 146085, 145685, 145674, 45088, 145862, 45095, 45676, 46144, 45108, 145300, 46044, 46169, 45537, 145026, 46290, 145758, 45084, 145270, 146117, 146092, 45195, 145631, 45684, 45940, 146114, 145666, 145380, 145816, 45120, 145921, 145842, 145554, 46232, 45135, 145710, 145044, 145686, 46279, 145638, 145367, 145170, 145689, 145187, 45495, 45298, 145164, 46176, 45399, 46261, 145334, 145633, 45375, 45351, 146128, 45276, 46179, 145610, 46048, 145810, 46168, 46121, 45705, 45284, 145669, 145831, 145206, 145667, 45477, 145104, 45112, 146075, 145445, 46032, 145544, 46050, 45212, 46276, 145687, 145099, 145256, 46161, 46020, 45761, 145338, 45736, 145541, 145545, 145259, 145952, 46149, 45149, 45407, 45327, 45944, 45006, 45371, 46238, 145130, 45983, 46189, 145700, 45236, 45201, 145747, 46273, 45520, 145774, 46303, 45116, 145262, 145663, 45456, 45624, 145754, 45599, 145148, 45690, 45963, 45346, 45995, 45293, 145179, 45770, 145161, 145145, 145620, 145476, 46127, 45435, 45155, 46047, 45295, 45160, 45603, 145892, 45543, 45847, 145269, 145770, 46259, 45817, 145827, 45856, 45526, 145731, 145640, 145266, 45117, 45324, 45968, 145775, 45372, 145454, 45249, 45958, 145343, 145255, 145110, 46286, 145609, 145790, 145030, 145011, 145012, 145105, 45219, 145061, 145533, 145532, 45774, 45167, 45069, 146105, 145924, 145113, 45085, 45741, 45147, 145193, 46289, 145622, 45121, 45150, 46175, 45536, 46237, 145032, 46191, 46143, 45733, 46081, 45158, 45110, 145492, 46100, 45379, 45318, 145394, 45681, 145886, 145491, 45425, 145761, 45031, 145632, 145182, 145124, 45996, 45107, 45428, 45635, 46021, 46007, 46105, 46142, 45203, 45018, 145850, 146102, 146100, 45019, 145826, 145521, 145860, 45417, 45928, 145097, 145323, 46205, 145325, 45906, 146115, 45815, 45042, 145594, 145801, 45500, 45986, 45202, 45553, 45381, 145020, 45566, 145990, 145728, 45959, 46009, 45134, 145447, 45474, 145149, 45099, 45349, 46150, 145143, 46016, 145605, 146127, 145785, 45623, 145089, 145209, 45835, 145302, 145815, 45082, 45079, 45878, 45452, 145246, 46086, 45850, 46239, 46140, 45773, 145293, 145127, 45556, 45870, 145486, 46026, 145485, 145403, 145624, 145245, 46034, 45455, 145443, 145297, 45288, 145582, 145772, 46297, 45667, 45430, 146090, 45074, 45585, 45128, 45239, 145386, 145489, 45328, 45580, 45122, 45078, 145449, 45387, 45804, 145536, 145569, 145781, 145629, 145504, 45682, 45072, 145565, 46222, 45948, 145718, 145282, 45056, 45970, 45408, 145066, 145796, 46310, 46311, 45273, 45214, 45631, 45386, 145275, 145704, 45406, 46107, 46102, 45080, 145717, 145320, 45220, 45424, 145522, 145230, 45228, 45348, 45649, 46190, 145142, 145636, 145222, 145111, 145598, 45181, 45229, 45105, 145839, 45840, 45685, 145292, 45132, 46288, 45291, 45857, 46157, 45266, 45839, 45208, 146078, 145450, 45307, 45982, 46145, 46298, 145169, 45237, 45869, 45230, 45205, 45694, 45507, 46281, 145311, 45232, 145662, 45390, 145087, 45255, 145332, 45409, 45559, 45130, 146120, 145197, 45777, 145072, 145626, 145794, 145864, 146122, 146121, 45669, 45801, 45436, 45545, 46201, 46080, 45945, 145227, 45093, 46243, 45818, 45071, 45111, 145075, 46294, 45199, 45638. Additional serial numbers added 11/14/2025: 45395, 45442, 45291.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2660-2025
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.