Z-1975-2013Class II

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Name: Z-1975-2013 Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-03-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-03-04 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system on 2013-03-04. FDA classified it as Class II and gives the reason as "Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and...". 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-1975-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-04
Posted: 2013-08-15
Terminated: 2015-03-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens, notified their customers on March 4, 2013 and sent a "Customer Safety Advisory Notice" letter dated April 03, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to always check whether the laterality information is displayed in the image text of mammography images; if not, the DICOM header is accessible and can be checked for the tag "Laterality" (0020, 0060). If a system is not able to provide the DICOM tag "Image Laterality" (0020, 0062), configuring the image text by adding the tag was proposed. If you have sold the device/equipment and it is no longer in your possession, forward this safety notice to the new owner of the device/equipment and inform us about the new owner of the device/equipment. This issue will be resolved in the syngo.plaza software version VA20D_HF04 which is planned to be released in 02/2013. Customers were also instructed to contact the local Siemens service office to plan the update. If you have any questions, contact the SYNGO CEO or Vice President Quality at +49 (9131) 84-4874 or email to: [email protected].
Quantity in commerce: 6
Distribution: Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
Product codes and lots: Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1975-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1975-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-15

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

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)