FDAFDA · Food and drugs·Recall number Z-1638-2014
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Published May 28, 2014 · Recall initiated: April 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Distributed in the states of GA, FL, NY, NV, and MA.
- Lot
- (Material number 10549894) with serial numbers 5000 through 5029.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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