syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807,
FDA device recall Z-1216-2014 · posted 2014-03-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
- Action taken
- A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 50
- Distribution
- Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
- Date initiated
- 2014-01-27
- Date posted
- 2014-03-18
- Date terminated
- 2015-03-16
- Location
- Malvern, PA
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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 |