Recall Z-0882-2026— Philips North America Llc

Name: FDA recall Z-0882-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-29

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-10-29. It names one FDA 510(k) clearance: K232491. Product: CT 5300; 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-29
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K232491 — CT 5300Philips Healthcare (Suzhou) Co., Ltd.·cleared 2024-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.