syngo Dynamics Version 9.5
FDA device recall Z-2219-2012 · posted 2012-08-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 Instruction SY064/121S.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 30
- Distribution
- Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
- Date initiated
- 2012-07-13
- Date posted
- 2012-08-17
- Date terminated
- 2013-07-15
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 9.0 (K102150) | Siemens Medical Solutions USA, Inc. | 2010-10-05 |