Health product recall

Respironics Ventilator

Last updated

Summary

Product
Respironics Ventilator
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

V60 Ventilator, Symbols Only, With Cflex And Avaps Options

All lots.

1053614

Respironics V680 Ventilator

All lots.

850011

Respironics V60 Plus Ventilator

All lots.

1137276

Issue

All V60/V60 plus and V680 units have been identified to have potential issue that could affect the main electrical circuit ("35V rail") powering the ventilator and alarm. In some cases, this issue may result in either one of the following scenarios:
1. The ventilator ceases to operate, activating both visual and audible alarms.
2. The ventilator ceases to operate and does not activate either a visual or audible alarm causing a "silent shutdown".

Recall start date: Mar 17, 2022

Additional information

Details
Original published date: 2022-03-31
Alert / recall type
Health product recall
Category
Health product - Medical device - Anaesthesiology
Companies

Respironics California LLC

2271 Cosmos Court, Carlsbad, California

United States, 92011

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64033