Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
FDA device recall Z-0827-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.
- Action taken
- The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 3
- Distribution
- Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.
- Date initiated
- 2011-05-01
- Date posted
- 2012-01-20
- Date terminated
- 2014-01-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO. PLAZA VA20A (K101666) | Siemens AG Medical Solutions | 2010-08-10 |