Device product
Biograph mCT Flow Edge-4R, System Material Number 10528955. 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-0807-2015
Product summary
- Event
- Event 69897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0807-2015
Official wording
Reason: Possibility for system display freeze during CT interventional procedures.
Code information: Serial Numbers: 11002, 11005, 11006, 11008
Distribution pattern: Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Derived failure modes
-
Unknown
Possibility for system display freeze during CT interventional procedures.