Fore-Sight Elite Tissue Oximeter Module
Brand(s)
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 products - Medical devices - 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