Device product
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Z-0580-2014
Product summary
- Firm
- EOS Imaging
- Event
- Event 66980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-0580-2014
Official wording
Reason: Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Code information: Software versions: 1.3, 1.4 and 1.5
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation