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Siemens Medical Solutions USA, Inc recalls Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies unde
Recalled December 17, 2014 · FDA recall Z-0523-2015 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
3
Sold at
US Nationwide Distribution in the state of: WV, NY, and FL..
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →