The FDA has posted 5 enforcement recalls of mammographic x-ray system full field digital devices since 2025, none of them Class I (most serious). Most recent report: May 20, 2026.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
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.
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.
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.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Full Field Digital, System, X-Ray, Mammographic”). Informational only — verify against the FDA before acting.