—#119958

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093612
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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: michael.mlb.braun@siemens.com.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.

Timeline

Recall initiated: 2013-03-04
Posted by FDA: 2013-08-15
Terminated: 2015-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.