FDA Device recall Z-2595-2025

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number:…

FDA Device
Class II
ongoing
Published 2025-10-01

On 2025-10-01 the FDA classified a Class II recall of Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number:… by Philips North America, citing the patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2595-2025
Classification	Class II
Status	ongoing
Initiated	2025-08-13
Published	2025-10-01
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	US

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.

Identifiers

code_info	1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A;… 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,

code_info

1. Model Number: 728235; UDI-DI: N/A; Serial Numbers: 9223, 9115, 9225, 29144. 2. Model Number: 728231; UDI-DI: N/A;…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2595-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.