Recall Z-1586-2023— Philips North America

Name: FDA recall Z-1586-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-20

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-03-20. It names 2 FDA 510(k) clearances: K212441, K180015. Product: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813. Reason: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury.

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-03-20
Firm location: Cambridge, MA, United States

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 -Computed Tomography X-Ray System Model Number: 72813

Reason for recall

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

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