Recall Z-1774-2021— Philips North America Llc

Name: FDA recall Z-1774-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-13

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2021-04-13, terminated 2022-09-23. It names one FDA 510(k) clearance: K060937. Product: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306. Reason: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2021-04-13
Terminated: 2022-09-23
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060937 — BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc.·cleared 2006-06-05

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

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Reason for recall

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

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