Syngo.Via VB20A model 1049610
FDA device recall Z-1778-2018 · posted 2018-05-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
- Action taken
- On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Distribution
- Nationwide
- Date initiated
- 2018-03-27
- Date posted
- 2018-05-09
- Date terminated
- 2020-06-15
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.VIA (K123375) | Siemens AG | 2012-11-20 |