FDA-Device2025-12-10Class IIMISBRANDING
MAMMOMAT Revelation;
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Affected count
7 units (3 US, 4 OUS)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
MAMMOMAT Revelation;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2026More Siemens recalls
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- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
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