🔍 RecallPedia

Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Class I - Dangerous
🏥 Medical Devices Recalled: March 24, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model #: 728231; Serial #s: 9009, 9029, 9033, 9037, 9038, 9043, 9045, 9051, 9052, 9056, 9058, 9064, 9065, 9067, 9068, 9070, 9072, 9073, 9075, 9086, 9089, 9092, 9104, 9105, 9106, 9107, 9108, 9112, 9120, 9139, 9151, 9152, 9156, 9190, 9243, 9259, 9502, 9503, 9504, 9507, 9508, 9511, 9512, 9515, 9516, 9522, 9525, 9526, 9529, 9530, 9531, 9533, 9534, 9545, 9547, 9550, 9551, 9556, 9561, 9564, 9572, 9577, 9580, 9584, 9591, 9594, 9596, 9598, 9603, 9606, 9607, 9608, 9612, 9613, 9614, 9618, 9620, 9624, 9625, 9626, 9628, 9630, 9633, 9634, 9635, 9639, 9640, 9641, 9642, 9646, 9648, 9650, 9655, 9663, 9666, 9667, 9672, 9676, 9678, 9685, 9686, 9690, 9691, 9692, 9694, 9695, 9697, 9700, 9705, 9706, 9709, 9713, 9716, 9726, 9729, 9732, 9735, 9736, 9738, 9740, 9750, 9751, 9752, 9753, 9754, 9757, 9759, 9760, 9761, 9775, 9777, 9780, 9781, 9788, 9790, 9793, 9794, 9802, 9805, 9809, 9811, 9812, 9821, 9823, 9826, 9830, 9833, 9835, 9843, 9846, 9855, 9857, 9860, 9861, 9866, 9869, 9870, 9873, 9875, 9876, 9878, 9879, 9881, 9882, 9885, 9888, 9889, 9890, 9894, 9895, 9902, 9906, 9910, 9916, 9917, 9918, 9924, 9936, 9937, 9938, 9942, 9948, 9951, 9954, 9960, 9961, 9965, 9966, 9968, 9969, 9974, 9975, 9978, 9980, 9982, 9985, 9992, 9993, 9994, 9999, 10001, 10005, 10014, 10018, 10026, 10030, 10031, 10035, 10036, 10037, 10041, 10045, 10046, 10051, 10054, 10065, 10067, 10070, 10072, 10079, 10080, 10085, 10086, 10094, 10095, 10096, 10098, 10103, 10111, 10112, 10113, 10120, 10122, 10125, 10141, 10148, 10190, 10194, 10200, 10202, 10203, 10211, 10224, 10256, 10263, 10291, 10292, 10310, 10332, 10353, 10359, 10363, 10365, 10370, 10371, 10372, 10373, 10380, 10381, 10386, 10388, 10413, 10417, 10424, 10426, 10473, 10486, 10505, 10513, 10527, 10535, 10561, 10570, 10645, 10651, 10655, 10673, 10686, 10733, 10743, 10773, 10776, 29005, 29007, 29016, 29018, 29025, 29027, 29035, 29037, 29053, 29054, 29068, 29097, 64015, 90031, 90047, 90062, 90063, 90128, 95003, 95008, 95022, 95057, 95058, 95068, 95149, 95197, 95210, 95348, 95357, 95377, 95392, 95403, 95811, 95341A, 9851T, 9172.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
Software defect causing intermittently slow response of Host.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Product Codes/Lot Numbers:

Model #: 728231; Serial #s: 9009, 9029, 9033, 9037, 9038, 9043, 9045, 9051, 9052, 9056, 9058, 9064, 9065, 9067, 9068, 9070, 9072, 9073, 9075, 9086, 9089, 9092, 9104, 9105, 9106, 9107, 9108, 9112, 9120, 9139, 9151, 9152, 9156, 9190, 9243, 9259, 9502, 9503, 9504, 9507, 9508, 9511, 9512, 9515, 9516, 9522, 9525, 9526, 9529, 9530, 9531, 9533, 9534, 9545, 9547, 9550, 9551, 9556, 9561, 9564, 9572, 9577, 9580, 9584, 9591, 9594, 9596, 9598, 9603, 9606, 9607, 9608, 9612, 9613, 9614, 9618, 9620, 9624, 9625, 9626, 9628, 9630, 9633, 9634, 9635, 9639, 9640, 9641, 9642, 9646, 9648, 9650, 9655, 9663, 9666, 9667, 9672, 9676, 9678, 9685, 9686, 9690, 9691, 9692, 9694, 9695, 9697, 9700, 9705, 9706, 9709, 9713, 9716, 9726, 9729, 9732, 9735, 9736, 9738, 9740, 9750, 9751, 9752, 9753, 9754, 9757, 9759, 9760, 9761, 9775, 9777, 9780, 9781, 9788, 9790, 9793, 9794, 9802, 9805, 9809, 9811, 9812, 9821, 9823, 9826, 9830, 9833, 9835, 9843, 9846, 9855, 9857, 9860, 9861, 9866, 9869, 9870, 9873, 9875, 9876, 9878, 9879, 9881, 9882, 9885, 9888, 9889, 9890, 9894, 9895, 9902, 9906, 9910, 9916, 9917, 9918, 9924, 9936, 9937, 9938, 9942, 9948, 9951, 9954, 9960, 9961, 9965, 9966, 9968, 9969, 9974, 9975, 9978, 9980, 9982, 9985, 9992, 9993, 9994, 9999, 10001, 10005, 10014, 10018, 10026, 10030, 10031, 10035, 10036, 10037, 10041, 10045, 10046, 10051, 10054, 10065, 10067, 10070, 10072, 10079, 10080, 10085, 10086, 10094, 10095, 10096, 10098, 10103, 10111, 10112, 10113, 10120, 10122, 10125, 10141, 10148, 10190, 10194, 10200, 10202, 10203, 10211, 10224, 10256, 10263, 10291, 10292, 10310, 10332, 10353, 10359, 10363, 10365, 10370, 10371, 10372, 10373, 10380, 10381, 10386, 10388, 10413, 10417, 10424, 10426, 10473, 10486, 10505, 10513, 10527, 10535, 10561, 10570, 10645, 10651, 10655, 10673, 10686, 10733, 10743, 10773, 10776, 29005, 29007, 29016, 29018, 29025, 29027, 29035, 29037, 29053, 29054, 29068, 29097, 64015, 90031, 90047, 90062, 90063, 90128, 95003, 95008, 95022, 95057, 95058, 95068, 95149, 95197, 95210, 95348, 95357, 95377, 95392, 95403, 95811, 95341A, 9851T, 9172.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2366-2016

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Philips Medical Systems (Cleveland)

Class I - Dangerous

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

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