FDA-Device2025-12-10Class IIMISBRANDING
MAMMOMAT Fusion;
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
1 unit (OUS only)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
MAMMOMAT Fusion;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2026More Siemens recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.