Z-1892-2010

Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS

Name: Z-1892-2010 Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-04-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-04-06 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS on 2010-04-06. The reason FDA records is "Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1892-2010
Status: Terminated
Initiated: 2010-04-06
Posted: 2010-06-24
Terminated: 2012-07-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.
Quantity in commerce: 3 units
Distribution: Nationwide Distribution -- Including CT, NM, & WI.
Product codes and lots: Material number 10014063. Serial numbers 1043, 1114, and 1198. Version Lines VB20, VB30, & VB35.

Product code LLZ

K082430Class IISyngo Imaging XsSiemens AG Medical Solutions / cleared 2008-11-14

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)