Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, repo
FDA device recall Z-1027-2015 · posted 2015-01-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.
- Action taken
- Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 50
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-01-13
- Date posted
- 2015-01-28
- Date terminated
- 2017-02-16
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA VB10A (K132532) | Siemens AG Healthcare | 2013-12-09 |
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |
| SIENET TELERADIOLOGY PRODUCT LINE (K955394) | Siemens Medical Solutions USA, Inc. | 1996-02-21 |