Z-0332-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2018
- Initiation Date
- November 8, 2017
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 134
Product Description
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Reason for Recall
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.
Distribution Pattern
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Code Information
Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present.