Recall Z-3158-2024— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-3158-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-23

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2023-11-23. It names one FDA 510(k) clearance: K170858. 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: 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..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-11-23
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K170858 — FDR AQRO (DR-XD 1000)Fujifilm Medical Systems U.S.A, Inc.·cleared 2017-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.