Recall Z-1273-2021— Philips Healthcare (Suzhou) Co., Ltd.

Name: FDA recall Z-1273-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare (Suzhou) Co., Ltd., initiated 2021-02-24, terminated 2023-02-17. It names one FDA 510(k) clearance: K180015. Product: Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.. Reason: Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position..

Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-02-24
Terminated: 2023-02-17
Firm location: Suzhou, N/A, China

510(k) clearances named in this recall

1 on FDA's record

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 CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.

Reason for recall

Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.

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