The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)
Summary
The FDA issued a Class II for The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI by FUJIFILM Healthcare Americas Corporation. 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 ch.
Details
Source
Device Recall
External ID
Z-3158-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
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.
Lot/Code Info: All serial numbers shipped from FUJIFILM
Quantity Affected: 130
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
Type: FDA Mandated
Recall Initiated: 2023-11-23
Company
Lexington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FUJIFILM Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3158-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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