Recall Z-1650-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
| Date | Jul 7, 2009 (initiated Jun 1, 2009) |
| Status | Terminated |
| Reason | Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations. |
| Root cause | Software design |
| Action | syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available. |
| Quantity | 16 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081734 | SYNGO IMAGING (VERSION V31) Siemens AG Medical Solutions, Jul 3, 2008 |