FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
- Recall number
- Z-1127-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
- Status
- Terminated
- Initiated
- 2012-01-20
- Posted
- 2012-02-29
- Terminated
- 2012-09-29
- Reason
- 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
- Root cause
- Software design
- Action
- 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.
- Quantity
- 7
- Distribution
- Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
- Lot, serial or model codes
- Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.
- 510(k) numbers
- ["K093612"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28