Syngo.via. Medical Device Software. Picture archiving and communications system.
FDA device recall Z-1303-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
- Action taken
- Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 236 units
- Distribution
- Device is software only. No products are distributed to wholesale dealers, distributers or retailers
- Date initiated
- 2018-01-08
- Date posted
- 2018-03-20
- Date terminated
- 2020-04-22
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.VIA (K123375) | Siemens AG | 2012-11-20 |