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Recall Observatory FDA recall evidence

Device product

Philips Healthcare IQon Spectral CT computed tomography x-ray system

Z-0333-2018

November 08, 2017

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 78879
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-0333-2018

Official wording

Reason: There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

Code information: IQon Spectral CT 728332 Devices manufactured 03/05/2009 to present.

Distribution pattern: 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.