Health Products

Fujifilm Mobile Digital X-Ray System FDR Nano

· Published by Health Canada · Official notice

Details

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

Affected productsLot or serial numberModel or catalogue number
Fujifilm Mobile Digital X-Ray System FDR NanoSN 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

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