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Recall Observatory FDA recall evidence

Device product

Brilliance iCT

Z-1058-2017

December 23, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 76144
Status
Terminated
Classification
Class II
Quantity
1-unit
Official record key
device-enforcement:Z-1058-2017

Official wording

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

Code information: Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203

Distribution pattern: Product was not distributed in the US. Unit was distributed in Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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