Z-1303-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- January 8, 2018
- Termination Date
- April 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 units
Product Description
Syngo.via. Medical Device Software. Picture archiving and communications system.
Reason for Recall
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Distribution Pattern
Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Code Information
Model Number 10496180