CanadaMonnal T60 Advanced ventilators (model/catalogue KA017124) with lot/serial numbers MT6A-02322, MT6A-02323, MT6A-02324 and MT6A-02325 are affected. Air Liquide Medical Systems found a manufacturing non-conformity: washers are missing beneath the screw head that secures the inspiratory unit, which calls into question conformity with standards EM 13718-1 and EN 1789+A1; contact the manufacturer for additional information.
What's being recalled
Companies: Air Liquide Medical Systems, 6 Rue Georges Besse, Antony, France, 92182.
How to identify it
Affected products: Monnal™ T60 Advanced; Lot or serial number: MT6A-02322; Model or catalogue number: KA017124
Affected products: Monnal™ T60 Advanced; Lot or serial number: MT6A-02324; Model or catalogue number: KA017124
Affected products: Monnal™ T60 Advanced; Lot or serial number: MT6A-02323; Model or catalogue number: KA017124
Affected products: Monnal™ T60 Advanced; Lot or serial number: MT6A-02325; Model or catalogue number: KA017124
The hazard
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).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)