FDA Device recall Z-0881-2026

Incisive CT

FDA Device
Class II
ongoing
Published 2025-12-10

On 2025-12-10 the FDA classified a Class II recall of Incisive CT by Philips North America, citing if the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components loca….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0881-2026
Classification	Class II
Status	ongoing
Initiated	2025-10-29
Published	2025-12-10
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	US

Product

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Reason

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Identifiers

code_info	1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264… 1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 5

code_info

1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264…

1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 5

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-0881-2026%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.