Z-1613-2014Class II

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance...

Name: Z-1613-2014 Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-04-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation... on 2014-04-03. FDA classified it as Class II and gives the reason as "Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display". 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-1613-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2014-05-13
Terminated: 2014-12-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.
Quantity in commerce: 50
Distribution: US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
Product codes and lots: model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1613-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

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)