Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of
FDA device recall Z-1705-2015 · posted 2015-06-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.
- Action taken
- Siemens sent a Customer Advisory Notice, dated May 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check the software version of their syngo.via system and consider whether the issue described in the advisory notice impact their clincal coutine and whether to arrange the installation of SY027/15/P (VA30A_HF07). Customers were advised to include the advisory notice in their operator's manual. Customers were also advised to notify anyone at their organization who should be aware of this information. For questions regarding this recall call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 167
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-05-15
- Date posted
- 2015-06-03
- Date terminated
- 2017-03-24
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.VIA (K123375) | Siemens AG | 2012-11-20 |
| SYNGO.X (K092519) | Siemens AG Medical Solutions | 2009-08-27 |