FDA recall Z-3158-2024

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

Reason for recall

When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

Distribution

US Nationwide and Worldwide

Key facts

Status
Ongoing
Initiation date
2023-11-23
Report date
2024-10-02
Voluntary/Mandated
FDA Mandated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3158-2024