Z-3158-2024 Class II Ongoing
FDA device recall Z-3158-2024 was initiated by FUJIFILM Healthcare Americas Corporation on November 23, 2023 and is designated Class II. 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 a… The recall status is ongoing. Affected quantity: 130.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- November 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 130
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.
Distribution Pattern
US Nationwide and Worldwide
Code Information
All serial numbers shipped from FUJIFILM