Health product recall

Fujifilm Mobile Digital X-Ray System FDR Nano

Last updated

Summary

Product
Fujifilm Mobile Digital X-Ray System FDR Nano
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Fujifilm Mobile Digital X-Ray System FDR Nano SN 67250049 SN 76250095 SN 96850884 DR-XD 1000

Issue

Fujifilm became aware that in rare cases, the arm base holding the tube section in DR-XD 1000 may get damaged. A protective hook will be attached to the equipment to prevent harm to patient even if the damage to the arm spreads. There have been no reported patient injuries associated with this issue.

Recall start date: February 18, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
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-77038

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