Z-1216-2014Class II

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806...

Name: Z-1216-2014 syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-01-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-01-27 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 on 2014-01-27. FDA classified it as Class II and gives the reason as "Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to...". 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-1216-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-27
Posted: 2014-03-18
Terminated: 2015-03-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
Root cause tag: software
FDA root cause: Software design
Action: A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014.
Quantity in commerce: 50
Distribution: Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
Product codes and lots: Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-18

Product code LLZ

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)