Public recall detail

Respironics Ventilator

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Recall Safety notice
Quick summary

Quick summary: Respironics Ventilator.

Recommended action

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Recall details

Quick summary: Respironics Ventilator.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRespironics California LLC
ProductRespironics Ventilator
IssueMedical devices - Software defect
Recall classType II
IdentificationRA-64033

Affected products

ProductV60 Ventilator, Symbols Only, With Cflex And Avaps Options
LotAll lots.
Model1053614
Serial numberAll lots.
DescriptionV60 Ventilator, Symbols Only, With Cflex And Avaps Options
ProductRespironics V680 Ventilator
LotAll lots.
Model850011
Serial numberAll lots.
DescriptionRespironics V680 Ventilator
ProductRespironics V60 Plus Ventilator
LotAll lots.
Model1137276
Serial numberAll lots.
DescriptionRespironics V60 Plus Ventilator

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesRespironics California LLC 2271 Cosmos Court, Carlsbad, California United States, 92011
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64033
Background{}
CompaniesRespironics California LLC 2271 Cosmos Court, Carlsbad, California United States, 92011
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-29

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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