Recall Monitor
Health Products

Monnal™ T60 Advanced

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Monnal™ T60 Advanced
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Monnal™ T60 AdvancedMT6A-02322KA017124
Monnal™ T60 AdvancedMT6A-02324KA017124
Monnal™ T60 AdvancedMT6A-02323KA017124
Monnal™ T60 AdvancedMT6A-02325KA017124

Issue

Air Liquide Medical Systems has identified a manufacturing non-conformity that affects a limited and specific number of Monnal T60 and Monnal T60 advanced devices. It concerns the failure to fit washers beneath the screw head that secures the inspiratory unit of the device. The absence of a washer calls into question the conformity of the Monnal T60 units concerned with the requirements of standard EM 13718-1 (Requirements for medical devices used in air ambulances) and standard EN 1789+A1 (Requirements for medical devices used in road ambulances).

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