Recall Monitor
Health Products

Digital Diagnostic Mobile X-Ray System GM85

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Digital Diagnostic Mobile X-Ray System GM85
Issue: Medical devices - Performance
What to do: Customers to be contacted to arrange visit for inspection and repair.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Digital Diagnostic Mobile X-Ray System GM85S/N 5143M3UJ200001NGM85

Issue

We have received a report regarding the loosening or breakage of bolts that connect the tube head unit (THU) to the arm. An investigation determined that this may be caused by metal fatigue resulting from accumulated stress over a long period of use. If all connecting bolts were to fail, it could potentially cause the THU to detach from the arm, posing a risk of serious injury to a patient or user.

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