FDA-Device2025-12-10Class II
MAMMOMAT Inspiration;
Siemens Medical Solutions USA, Inc
Hazard
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Sold states
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Affected count
6 units (3 US, 3 OUS)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
MAMMOMAT Inspiration;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2026Don't want to check this manually?
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