Recall Z-2258-2023— Philips North America

Name: FDA recall Z-2258-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-25

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-04-25. It names one FDA 510(k) clearance: K180015. Product: Incisive CT-Computed Tomography X-Ray System Model: 728143. Reason: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down.

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2023-04-25
Firm location: Cambridge, MA, United States

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

Incisive CT-Computed Tomography X-Ray System Model: 728143

Reason for recall

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

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