Device product
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Z-2000-2016
Product summary
- Event
- Event 74239
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2000-2016
Official wording
Reason: The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Code information: Serial Number 11022
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Derived failure modes
-
Unknown
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.