—#147498

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123420
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND

Timeline

Recall initiated: 2016-06-06
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.