Recall Z-1921-2020— Philips North America, LLC

Name: FDA recall Z-1921-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-06

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-06, terminated 2022-09-16. It names one FDA 510(k) clearance: K060937. Product: Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848. Reason: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-06
Terminated: 2022-09-16
Firm location: Andover, 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

Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

Reason for recall

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

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