Health product recall

Sevoflurane, Desflurane, and Isoflurane Electronic Vaporizer Material Package

Last updated

Summary

Product
Sevoflurane, Desflurane, and Isoflurane Electronic Vaporizer Material Package
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Sevoflurane (Quik-Fil) Electronic Vaporizer Material Package

More than 10 numbers, contact manufacturer.

115-066755-00

Desflurane (Saf-T-Fill) Electronic Vaporizer Material Package

More than 10 numbers, contact manufacturer.

115-066759-00

Isoflurane (Safety Filling Adapter) Electronic Vaporizer Material Package

More than 10 numbers, contact manufacturer.

115-066758-00

Issue

The anesthesia system is a device used to administer a general inhalation anesthetic continuously or intermittently to a patient and maintain their ventilation. The A9 anesthesia system utilizes electronic vaporizers (V90) for anesthetic agent delivery.

Mindray has become aware of a potential issue with select batches of V90 electronic vaporizers.

The V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 anesthesia system will generate alarms associated with abnormal vaporizer output. We recommend that the user use the part number reference to identify the license and the device identifier.

Recall start date: July 22, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Building, Suite 3b, Shenzhen, Guangdong, China, 518057

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75948

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