FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2024 - (Recall #: Z-3158-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 23, 2023

Date Posted: October 2, 2024

Recall Number: Z-3158-2024

Event ID: 95320

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.

Status: Ongoing

Product Quantity: 130

Code Information:

All serial numbers shipped from FUJIFILM

Distribution Pattern:

US Nationwide and Worldwide

Voluntary or Mandated:

FDA Mandated