Device product
Biograph mCT X-4R, System Material Number 10248670. 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-0809-2015
Product summary
- Event
- Event 69897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units total
- Official record key
device-enforcement:Z-0809-2015
Official wording
Reason: Possibility for system display freeze during CT interventional procedures.
Code information: Serial Number: 1003
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.