Product Wiki · Recalls · U.S. FDA — Device Enforcement

Philips Healthcare Brilliance iCT computed tomography x-ray system — recall Z-0331-2018

U.S. FDA — Device Enforcement · United States · 2017-11-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0331-2018
Date of alert
2017-11-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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