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Health Canada Medical devices

Respironics Ventilator

Issued March 29, 2022
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
Hazard description
Software defect
Product
Product name
Respironics Ventilator
Reference
ID
RA-64033