Recall archive / FDA device enforcement
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 C... — FDA record Z-2595-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 181 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2595-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 1, 2025
- Recall initiation date
- Aug 13, 2025
- Center classification date
- Sep 19, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.