Monnal™ T60 Advanced
Brand(s)
Last updated
Summary
Product
Monnal™ T60 Advanced
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Monnal™ T60 Advanced | MT6A-02322 | KA017124 |
| Monnal™ T60 Advanced | MT6A-02324 | KA017124 |
| Monnal™ T60 Advanced | MT6A-02323 | KA017124 |
| Monnal™ T60 Advanced | MT6A-02325 | KA017124 |
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).
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Air Liquide Medical Systems
6 Rue Georges Besse, Antony, France, 92182
Published by
Health Canada
Audience
Industry
Recall class
Type II
Recall date
Identification number
RA-81994
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