Device product
Syngo.via. Medical Device Software. Picture archiving and communications system.
Z-1303-2018
Product summary
- Event
- Event 79532
- Status
- Terminated
- Classification
- Class II
- Quantity
- 236 units
- Official record key
device-enforcement:Z-1303-2018
Official wording
Reason: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Code information: Model Number 10496180
Distribution pattern: Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Derived failure modes
-
Unknown
A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.