Recall Z-0732-2008 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
| Date | Feb 23, 2008 (initiated Nov 27, 2007) |
| Status | Terminated |
| Reason | Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high) |
| Root cause | Software design |
| Action | The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released. |
| Quantity | 10 units |
| Distribution | Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071114 | SYNGO IMAGING (VERSION V30) Siemens AG Medical Solutions, May 22, 2007 |