Recall Z-1705-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
| Date | Jun 3, 2015 (initiated May 15, 2015) |
| Status | Terminated |
| Reason | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 167 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |