Portable X-Ray Unit FDR Xair
Brand(s)
Last updated
Summary
Product
Portable X-Ray Unit FDR Xair
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Portable X-Ray Unit FDR Xair |
All lots. |
XD2000 PX |
Issue
The residual risk information of the XD2000 provided was not sufficient. There is the potential defectiveness for users to be exposed to unnecessary radiation by unintended handheld use. The users should understand the notification letter issued by FujiFilm and operate the XD2000 in accordance with the revised operation manual.
Recall Start Date: February 26, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Fujifilm Corporation
26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77064
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