Recall Z-1265-2021— Philips North America Llc

Name: FDA recall Z-1265-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-22

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2021-02-22, terminated 2023-02-09. It names one FDA 510(k) clearance: K180015. Product: Incisive CT Computed Tomography X-ray System Model: 728143. Reason: Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Terminated: 2023-02-09
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

Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees

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