Z-2219-2012Class II

syngo Dynamics Version 9.5

Name: Z-2219-2012 syngo Dynamics Version 9.5
Creator: Siemens Medical Solutions, USA, Inc
Published: 2012-07-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-07-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of syngo Dynamics Version 9.5 on 2012-07-13. FDA classified it as Class II and gives the reason as "If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study". 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-2219-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-08-17
Terminated: 2013-07-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Dynamics Version 9.5
Product code: LLZ System, Image Processing, Radiological
Reason for recall: If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
Root cause tag: software
FDA root cause: Software design
Action: On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.
Quantity in commerce: 30
Distribution: Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
Product codes and lots: 10091862 and 10091863

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2219-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2219-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-17

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