Syngo.via. Medical Device Software. Picture archiving recall: Software Issue
Syngo.via. Medical Device Software. Picture archiving and communications system.
Why was Syngo.via. Medical Device Software. Picture archiving recalled?
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 10496180
- Product
- Syngo.via. Medical Device Software. Picture archiving and communications system.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 236 units
- Distribution
- Device is software only. No products are distributed to wholesale dealers, distributers or retailers
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)