Recall Z-1058-2017— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1058-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-12-23, terminated 2018-06-26. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT. Reason: During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Terminated: 2018-06-26
Firm location: Cleveland, OH, 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 iCT

Reason for recall

During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.

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