Z-1859-2013Class II

syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for...

Name: Z-1859-2013 syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-06-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-06-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive... on 2013-06-10. FDA classified it as Class II and gives the reason as "Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close...". 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-1859-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-08-01
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo Dynamics is not intended to be used for reading mammography images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS. Update instructions were also provided. The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future. We regret any inconvenience that this may cause , and we thank you in advance for your understanding. For further questions please call (610) 219-6300.
Quantity in commerce: 9
Distribution: US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
Product codes and lots: Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1859-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1859-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code LLZ

K102150Class IISyngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. / cleared 2010-10-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)