Recall Monitor
Health Products

Monnal™ T60 Ventilator

· Published by Health Canada · Official notice

Details

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

Affected productsLot or serial numberModel or catalogue number
Monnal™ T60 VentilatorNot applicable.KA017115
Expiratory Valve Monnal EVA V2Not applicable.KY732991

Issue

The Monnal EVA V2 (2nd generation - expiratory valve) used on Monnal T60/T60 Advanced ventilators can lead to under-delivery of volumes in "child/infant" patients due to poor membrane sealing. No patient incidents have been reported; the detection occurred during tests. Air liquide medical systems is recalling these valves to replace them with the first generation to prevent the risk of hypoventilation.

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