Recalls / —
—#127169
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
- 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 number 10549894) with serial numbers 5000 through 5029.
Why it was recalled
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
Root cause (FDA determination)
Device Design
Action the firm took
A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Distributed in the states of GA, FL, NY, NV, and MA.
Timeline
- Recall initiated
- 2014-04-25
- Posted by FDA
- 2014-05-20
- Terminated
- 2014-12-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.