Recall Z-1003-2026— Philips Healthcare (Suzhou) Co., Ltd.

Name: FDA recall Z-1003-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-03

Class II · Ongoing

Class II FDA medical device recall by Philips Healthcare (Suzhou) Co., Ltd., initiated 2025-12-03. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Philips Incisive CT. Reason: Potential for incomplete scan due to unstable connection inside of floating sensor..

Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-03
Firm location: Suzhou, China

510(k) clearances named in this recall

2 on FDA's record

K212441 — Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2022-04-27
K180015 — Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2018-03-20

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

Philips Incisive CT

Reason for recall

Potential for incomplete scan due to unstable connection inside of floating sensor.

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