Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, displ
FDA device recall Z-1613-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
- Action taken
- Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 50
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
- Date initiated
- 2014-04-03
- Date posted
- 2014-05-13
- Date terminated
- 2014-12-15
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO DYNAMICS, VERSION 9.0 (K102150) | Siemens Medical Solutions USA, Inc. | 2010-10-05 |
| KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K023772) | Acuson Corp. | 2002-11-22 |