CanadaHamilton Medical AG Breathing Set MRI (model/catalogue numbers 260167 and 260168; lot/serial not applicable) is affected. Certain expiratory valve sets pre‑assembled to the breathing circuit can have the expiratory valve membrane adhere to the sealing ring, impairing valve opening and expiratory gas flow, which can raise end‑expiratory pressure or lower end‑expiratory flow and trigger the high‑priority alarm “Exhalation Obstructed”; obstructed air may be released through the device so the patient can exhale via the inspiratory limb. Contact the manufacturer for additional information.
What's being recalled
Companies: Hamilton Medical AG, Via Crusch 8, Bonaduz, Switzerland, 7402.
How to identify it
Affected products: Breathing Set MRI; Lot or serial number: Not applicable.; Model or catalogue number: 260167
Affected products: Breathing Set MRI; Lot or serial number: Not applicable.; Model or catalogue number: 260168
The hazard
Certain lots of the expiratory valve set pre-assembled to the breathing circuit set, coaxial (see FSN) do not perform as intended. In some cases, the expiratory valve membrane adhered to the expiratory valve body's sealing ring, thereby impairing valve opening and expiratory gas flow. The issue is not detected during the pre-operative test of the ventilator unless a test lung is actively ventilated. In case of an adhering expiratory valve membrane, the malfunction appears within the first breaths after ventilation is initiated.
When the expiratory gas flow is impeded, the end-expiratory pressure is too high, or the end-expiratory flow is too low. Consequently, the ventilator triggers the high priority alarm "Exhalation Obstructed".
The obstructed air is released through the device, e.g.the obstruction valve opens so that the patient can exhale through the inspiratory limb.
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)
United States