Recall Monitor
Health Products

Portable X-Ray Unit FDR Xair

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Portable X-Ray Unit FDR XairAll 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

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