Brilliance iCT
FDA Recall #Z-1058-2017 — Class II — December 23, 2016
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.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1-unit
Distribution
Product was not distributed in the US. Unit was distributed in Australia.
Code Information
Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated