Z-1127-2012

Siemens syngo.plaza with software version VA20B_HF04

Name: Z-1127-2012 Siemens syngo.plaza with software version VA20B_HF04
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-01-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-01-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system on 2012-01-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1127-2012
Status: Terminated
Initiated: 2012-01-20
Posted: 2012-02-29
Terminated: 2012-09-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: software
FDA 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 in commerce: 7
Distribution: Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
Product codes and lots: Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)