—#131347

Product

Mammomat Inspiration system: Product Usage: 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: model number: 10140000

Why it was recalled

It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.

Root cause (FDA determination)

Use error

Action the firm took

A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the state of: WV, NY, and FL..

Timeline

Recall initiated: 2014-10-28
Posted by FDA: 2014-12-06
Terminated: 2015-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131347. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.