🔍 RecallPedia

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A; Serial Numbers: 95647, 9194, 95341, 95234, 10051, 95488, 10098, 95695, 10309, 95217, 95698, 10443, 10544, 10531, 10712, 10662, 95834, 9990, 9784, 95632, 9058, 9089, 9522, 9580, 9688, 9877, 9806, 9808, 9671, 9694, 9703, 9830, 29068, 9821, 9869, 9837, 90144, 95203, 95225, 95303, 95328, 95362, 95402, 95395, 9852, 95492, 95491, 9965, 9974, 95453, 95502, 10006, 10025, 95520, 10060, 95630, 95621, 10141, 95673, 10153, 10137, 95521, 90128, 9605, 10218, 10199, 10247, 10275, 10267, 10245, 10394, 10307, 90124, 10281, 95692, 29045, 95349, 95639, 10344, 10330, 10310, 10348, 10391, 10393, 10418, 10205, 9799, 10429, 29062, 10511, 10431, 10515, 10535, 10315, 10521, 10518, 10566, 10536, 10522, 10496, 10560, 10568, 90170, 10433, 10574, 10609, 10559, 10468, 95725, 10622, 95710, 95729, 10590, 10628, 10683, 10668, 10666, 10607, 95758, 10706, 95776, 95821, 95757, 95858, 95795, 9868, 10729, 95791, 10734, 10718, 95807, 10649, 95781, 95790, 95823, 95813, 10788, 10774, 95759, 95852, 95848, 95116, 95872, 95871, 95914, 95886, 95498, 95054, 95928, 95933, 95025, 90162, 95144, 29039, 95932, 95399, 10031, 90804, 10161, 10494, 9934, 90161. 3. Model Number: 728317; UDI-DI: N/A; Serial Numbers: 345040, 345053, 345155, 345031, 345048, 345056, 345055, 345063, 345050, 345100, 345117, 345122, 345133, 345131, 345171.
  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 North America Llc
Reason for Recall:
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317

Product Codes/Lot Numbers:

1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A; Serial Numbers: 95647, 9194, 95341, 95234, 10051, 95488, 10098, 95695, 10309, 95217, 95698, 10443, 10544, 10531, 10712, 10662, 95834, 9990, 9784, 95632, 9058, 9089, 9522, 9580, 9688, 9877, 9806, 9808, 9671, 9694, 9703, 9830, 29068, 9821, 9869, 9837, 90144, 95203, 95225, 95303, 95328, 95362, 95402, 95395, 9852, 95492, 95491, 9965, 9974, 95453, 95502, 10006, 10025, 95520, 10060, 95630, 95621, 10141, 95673, 10153, 10137, 95521, 90128, 9605, 10218, 10199, 10247, 10275, 10267, 10245, 10394, 10307, 90124, 10281, 95692, 29045, 95349, 95639, 10344, 10330, 10310, 10348, 10391, 10393, 10418, 10205, 9799, 10429, 29062, 10511, 10431, 10515, 10535, 10315, 10521, 10518, 10566, 10536, 10522, 10496, 10560, 10568, 90170, 10433, 10574, 10609, 10559, 10468, 95725, 10622, 95710, 95729, 10590, 10628, 10683, 10668, 10666, 10607, 95758, 10706, 95776, 95821, 95757, 95858, 95795, 9868, 10729, 95791, 10734, 10718, 95807, 10649, 95781, 95790, 95823, 95813, 10788, 10774, 95759, 95852, 95848, 95116, 95872, 95871, 95914, 95886, 95498, 95054, 95928, 95933, 95025, 90162, 95144, 29039, 95932, 95399, 10031, 90804, 10161, 10494, 9934, 90161. 3. Model Number: 728317; UDI-DI: N/A; Serial Numbers: 345040, 345053, 345155, 345031, 345048, 345056, 345055, 345063, 345050, 345100, 345117, 345122, 345133, 345131, 345171.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2595-2025

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