Public recall detail

Trilogy EV300

2023-03-29

medium
Recall Safety notice
Quick summary

Quick summary: Trilogy EV300. Date: 2023-03-29.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Trilogy EV300. Date: 2023-03-29.

Official details

Affected product details

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

BrandRespironics Inc. Also Trading As Philips Rs North America Llc
ProductTrilogy EV300
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73404

Affected products

ProductTrilogy EV300
LotAll lots.
ModelCA2200X12B
Serial numberAll lots.
DescriptionTrilogy EV300

Issue

Philips Respironics has discovered that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FioO2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient's lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen. Recall start date: March 3, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC 1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73404
Background{}
CompaniesRespironics Inc. Also Trading As Philips Rs North America LLC 1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
AudiencesHealthcare Industry
Source updated2023-03-29

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

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