Recall Z-1638-2014
Siemens Medical Solutions USA, Inc · initiated April 25, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Codes / lots: (Material number 10549894) with serial numbers 5000 through 5029.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1638-2014
- Initiated
- April 25, 2014
- Posted by FDA
- May 20, 2014
- Terminated
- December 15, 2014
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 5
- Distribution
- Distributed in the states of GA, FL, NY, NV, and MA.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA