FDA-Device2014-12-17Class II
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.
Siemens Medical Solutions USA, Inc
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.
Sold states
US Nationwide Distribution in the state of: WV, NY, and FL..
Affected count
3
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2015Don't want to check this manually?
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