🇨🇦 Monnal™ T60 Advanced
Hazard/Reason: 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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