Recall Z-2275-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
| Date | Aug 27, 2012 (initiated Jul 18, 2012) |
| Status | Terminated |
| Reason | There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions. |
| Root cause | Software design |
| Action | The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software ver |
| Quantity | 14 |
| Distribution | Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101666 | SYNGO. PLAZA VA20A Siemens AG Medical Solutions, Aug 10, 2010 |