—#130325

Product

Siemens Mammomat Inspiration mammography systems. 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: material #10140000, with serial numbers: 5018 3849 5042

Why it was recalled

The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

Root cause (FDA determination)

Process control

Action the firm took

A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.

Recalling firm

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

Distribution

Distribution pattern: US Distribution in states of: NY, VA, and MA.

Timeline

Recall initiated: 2014-09-18
Posted by FDA: 2014-10-17
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130325. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.