Recall Z-2219-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions, USA, Inc
syngo Dynamics Version 9.5
| Date | Aug 17, 2012 (initiated Jul 13, 2012) |
| Status | Terminated |
| Reason | If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. |
| Root cause | Software design |
| Action | On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Ins |
| Quantity | 30 |
| Distribution | Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102150 | SYNGO DYNAMICS, VERSION 9.0 Siemens Medical Solutions USA, Inc., Oct 5, 2010 |