Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
FDA device recall Z-1127-2012 · posted 2012-02-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deleti
- Action taken
- Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 7
- Distribution
- Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
- Date initiated
- 2012-01-20
- Date posted
- 2012-02-29
- Date terminated
- 2012-09-29
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |