Z-2107-2016Class II

SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital...

Name: Z-2107-2016 SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-06-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-06-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets on 2016-06-06. FDA classified it as Class II and gives the reason as "Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus...". 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-2107-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-06
Posted: 2016-06-30
Terminated: 2017-01-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
Root cause tag: software
FDA root cause: Other
Action: Siemens mailed customers a letter to inform them about improvements that were made to the SYNGO Breast Care reading software to correct certain behaviors that were being seen during use. Customers were asked to upgrade their systems to this new version.
Quantity in commerce: 29 units
Distribution: Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND
Product codes and lots: Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

Product code LLZ

K123420Class IISyngo, Breast CareSiemens Medical Solutions USA, Inc. / cleared 2013-02-01

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)