Z-1105-2013Class II

Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system...

Name: Z-1105-2013 Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-10-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-10-05 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology... on 2012-10-05. FDA classified it as Class II and gives the reason as "Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when...". 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-1105-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-05
Posted: 2013-04-12
Terminated: 2013-07-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical sent a Customer Safety Advisory Notice letter dated October 5, 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. There will be a Hot Fix available. If you have any further questions please contact Siemens Customer Product Support at (1-888) 767-8326.
Quantity in commerce: 37
Distribution: Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.
Product codes and lots: Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1105-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1105-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-12

Product code LLZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)