🔍 RecallPedia

Brilliance iCT Computed Tomography X-ray Systems, 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: February 5, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. 728306; S/N: 85004, 85010, 85012, 85013, 85014, 85015, 85016, 85017, 85018, 85021, 85022, 85023, 85024, 85025, 85026, 85027, 85028, 85029, 85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040, 85043, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85051, 85054, 85055, 85056, 85057, 85058, 85059, 85060, 85061, 85062, 85065, 85066, 85067, 85068, 85069, 85070, 100016, 100018, 100019, 100025, 100037, 100038, 100040, 100044, 100048, 100049, 100050, 100051, 100058, 100062, 100064, 100065, 100070, 100072, 100082, 100084, 100091, 100099, 100101, 100103, 100111, 100113, 100114, 100115, 100119, 100122, 100133, 100134, 100135, 100140, 100144, 100149, 100153, 100161, 100162, 100170, 100178, 100180, 100181, 100184, 100185, 100190, 100191, 100192, 100200, 100214, 100215, 100217, 100221, 100222, 100228, 100231, 100236, 100247, 100260, 100270, 100271, 100273, 100274, 100278, 100280, 100281, 100302, 100304, 100308, 100309, 100310, 100314, 100318, 100325, 100329, 100343, 100346, 100350, 100351, 100356, 100360, 100365, 100368, 100370, 100374, 100393, 100396, 100398, 100399, 100400, 100402, 100405, 100406, 100416, 100423, 100436, 100441, 100446, 100449, 100450, 100452, 100453, 100461, 100462, 100463, 100464, 100465, 100466, 100469, 100472, 100483, 100493, 100494, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100517, 100518, 100520, 100521, 100522, 100600, 100601, 100602, 100603, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100691, 100692, 100693, 100695, 100696, 100697, 100698, 100699, 100701, 100702, 100704, 100705, 100706, 100707, 100708, 200004, 200005 & 200098.
  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 was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance iCT Computed Tomography X-ray Systems, 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 No. 728306; S/N: 85004, 85010, 85012, 85013, 85014, 85015, 85016, 85017, 85018, 85021, 85022, 85023, 85024, 85025, 85026, 85027, 85028, 85029, 85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040, 85043, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85051, 85054, 85055, 85056, 85057, 85058, 85059, 85060, 85061, 85062, 85065, 85066, 85067, 85068, 85069, 85070, 100016, 100018, 100019, 100025, 100037, 100038, 100040, 100044, 100048, 100049, 100050, 100051, 100058, 100062, 100064, 100065, 100070, 100072, 100082, 100084, 100091, 100099, 100101, 100103, 100111, 100113, 100114, 100115, 100119, 100122, 100133, 100134, 100135, 100140, 100144, 100149, 100153, 100161, 100162, 100170, 100178, 100180, 100181, 100184, 100185, 100190, 100191, 100192, 100200, 100214, 100215, 100217, 100221, 100222, 100228, 100231, 100236, 100247, 100260, 100270, 100271, 100273, 100274, 100278, 100280, 100281, 100302, 100304, 100308, 100309, 100310, 100314, 100318, 100325, 100329, 100343, 100346, 100350, 100351, 100356, 100360, 100365, 100368, 100370, 100374, 100393, 100396, 100398, 100399, 100400, 100402, 100405, 100406, 100416, 100423, 100436, 100441, 100446, 100449, 100450, 100452, 100453, 100461, 100462, 100463, 100464, 100465, 100466, 100469, 100472, 100483, 100493, 100494, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100517, 100518, 100520, 100521, 100522, 100600, 100601, 100602, 100603, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100691, 100692, 100693, 100695, 100696, 100697, 100698, 100699, 100701, 100702, 100704, 100705, 100706, 100707, 100708, 200004, 200005 & 200098.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1352-2016

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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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