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Hamilton medical ag breathing set mri

Official notice

28 May 2026

MediumHealth Canada

An official Health Canada notice concerns Hamilton medical ag breathing set mri. 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. Published 2026-05-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82133

Official notice

2026-05-28

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

260167, 260168

Other

RA RA-82133

Model Numbers

260167, 260168

Recall Numbers

82133

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Affected products

Product 1

Lot or serial number - Not applicable., Model or catalogue number - 260167

Product 2

Lot or serial number - Not applicable., Model or catalogue number - 260168

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Hamilton Medical.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82133

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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