Z-1972-2015Class II

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS)...

Name: Z-1972-2015 SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS)...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-06-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-06-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report... on 2015-06-11. FDA classified it as Class II and gives the reason as "During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size". 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-1972-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-11
Posted: 2015-07-02
Terminated: 2017-03-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.
Quantity in commerce: 5
Distribution: US in the states of NC and NE
Product codes and lots: model number: 10014064 serial numbers: 5846 5847 4333 4334 4335

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1972-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

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)