—#152613

Product

Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K122286
Affected lot / code info: Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560 6524 6412 6442 5018 6675 8038 6575 6045 3122 6871 3243 4571 6259 6469 6676 6474 6640 6452 6561 6801 2098 4161 6483 6344 6288 6594 8002 6610 6394 4018 6502 6080 4214 6893 6093 3118 6601 5042 6246 3088 4525 6870

Why it was recalled

Software error

Root cause (FDA determination)

Software design

Action the firm took

Siemens mailed a Customer Safety Advisory Notice (CSAN) letter dated January 11, 2017 to affected customers. The letter identified the affected product, the potential risks and the steps to take to avoid the risks associated with the issue. The letter also stated Siemens will release a field modification (software update) to resolve the issue as soon as possible. The new software will be provided to affected customers free of charge.

Recalling firm

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

Distribution

Distribution pattern: United States Nationwide Distribution

Timeline

Recall initiated: 2017-01-11
Terminated: 2017-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152613. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.