—#119086

Product

Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

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, serial numbers 3118, 3243 and 3309

Why it was recalled

Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.

Recalling firm

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

Distribution

Distribution pattern: United States Nationwide Distribution in the states of ND, OH and SC.

Timeline

Recall initiated: 2013-02-28
Posted by FDA: 2013-07-11
Terminated: 2014-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.