🔍 RecallPedia

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Class I - Dangerous
🏥 Medical Devices Recalled: September 14, 2015 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070, 6085, 6090, 6107, 6111, 6117, 6133, 6147, 6153, 6156, 6161, 6162, 6231, 6255, 6491, 6556, 657, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715, 6716, 6717, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6725, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6733, 6734, 6735, 6736, 6737, 6738, 6740, 6741, 6742, 6743, 6744, 6745, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6763, 6764, 6765, 6766, 6767, 6768, 6769, 6770, 6771, 6772, 6773, 6774, 6775, 6776, 6777, 6778, 6779, 6780, 6781, 6782, 6783, 6784, 30033, 30049, 30063, 30070, 30075, 30103, 30115, 30123, 40013, 40018, 50026, 50043, 50068, 50177, 50182, 50189, 50195, 50198, 50200, 50213, 50216, 50217, 50218, 50219, 50220, 50221, 50222, 50223, 50224, 50225, 50226, 50227, 50228, 260010, 260011, 260013, 260014, 260015, 260016, 260017, 260018, 260032, 260033, 260035, 260036, 260037, 260038, 260039, 260047, 260048, 260049, 260050, 260051, 260052, 260053, 260054, 260055, 260056, 260057, 260058, 260059, 260060, 260061, 260062, 260063, 260064, 260065, 260066, 260067, 260068, 260069, 260070, 260071, 260072, 260073, 260074, 260075, 260076, 260077, 260078, 260079, 260080, 260081, 260082, 260083, 260084, 260085, 260086, 260087, 260088, 260089 & 260090.
  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:
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Product Codes/Lot Numbers:

Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070, 6085, 6090, 6107, 6111, 6117, 6133, 6147, 6153, 6156, 6161, 6162, 6231, 6255, 6491, 6556, 657, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715, 6716, 6717, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6725, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6733, 6734, 6735, 6736, 6737, 6738, 6740, 6741, 6742, 6743, 6744, 6745, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6763, 6764, 6765, 6766, 6767, 6768, 6769, 6770, 6771, 6772, 6773, 6774, 6775, 6776, 6777, 6778, 6779, 6780, 6781, 6782, 6783, 6784, 30033, 30049, 30063, 30070, 30075, 30103, 30115, 30123, 40013, 40018, 50026, 50043, 50068, 50177, 50182, 50189, 50195, 50198, 50200, 50213, 50216, 50217, 50218, 50219, 50220, 50221, 50222, 50223, 50224, 50225, 50226, 50227, 50228, 260010, 260011, 260013, 260014, 260015, 260016, 260017, 260018, 260032, 260033, 260035, 260036, 260037, 260038, 260039, 260047, 260048, 260049, 260050, 260051, 260052, 260053, 260054, 260055, 260056, 260057, 260058, 260059, 260060, 260061, 260062, 260063, 260064, 260065, 260066, 260067, 260068, 260069, 260070, 260071, 260072, 260073, 260074, 260075, 260076, 260077, 260078, 260079, 260080, 260081, 260082, 260083, 260084, 260085, 260086, 260087, 260088, 260089 & 260090.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0173-2016

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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.

Aug 5, 2025 Other Medical Devices Nationwide View Details →