Health product recall

Fore-Sight Elite Tissue Oximeter Module

Last updated

Summary

Product
Fore-Sight Elite Tissue Oximeter Module
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Fore-Sight Elite Tissue Oximeter Module

More than 10 numbers, contact manufacturer.

HEMFSM10

Issue

The STO2 values may be inaccurately low when using either the fore-sight elite tissue oximeter module (Model HEMFSM10) or the fore-sight elite absolute tissue oximeter monitor (Model 01-06-3000) with the fore-sight elite large sensor (FSESL) in certain somatic locations (arms and legs). While the STO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change

Recall date: Feb 28, 2022

Additional information

Details
Original published date: 2021-11-03
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Edwards Lifesciences LLC

1 Edwards Way, Irvine, California

United States, 92614

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63532