Public recall detail

Portable X-Ray Unit FDR Xair

2025-03-05

medium
Recall Safety notice
Quick summary

Quick summary: Portable X-Ray Unit FDR Xair. Date: 2025-03-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Portable X-Ray Unit FDR Xair. Date: 2025-03-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandFujifilm Corporation
ProductPortable X-Ray Unit FDR Xair
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-77064

Affected products

ProductPortable X-Ray Unit FDR Xair
LotAll lots.
ModelXD2000 PX
Serial numberAll lots.
DescriptionPortable X-Ray Unit FDR Xair

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesFujifilm Corporation 26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77064
Background{}
CompaniesFujifilm Corporation 26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
AudiencesHealthcare
Source updated2025-03-05

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...