Public recall detail

Fore-Sight Elite Tissue Oximeter Module

2021-11-03

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Recall Safety notice
Quick summary

Quick summary: Fore-Sight Elite Tissue Oximeter Module. Date: 2021-11-03.

Recommended action

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

Recall details

Quick summary: Fore-Sight Elite Tissue Oximeter Module. Date: 2021-11-03.

Official details

Affected product details

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

BrandEdwards Lifesciences LLC
ProductFore-Sight Elite Tissue Oximeter Module
IssueMedical devices - Inaccurate test or measurement results
Recall classType II
IdentificationRA-63532

Affected products

ProductFore-Sight Elite Tissue Oximeter Module
LotMore than 10 numbers, contact manufacturer.
ModelHEMFSM10
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionFore-Sight Elite Tissue Oximeter Module

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Cardiovascular
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California United States, 92614
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63532
Background{}
CompaniesEdwards Lifesciences LLC 1 Edwards Way, Irvine, California United States, 92614
AudiencesGeneral public Health professionals Hospitals
Source updated2022-05-09

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

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