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Health Canada Medical devices

Fore-Sight Elite Tissue Oximeter Module

Issued May 9, 2022
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
Hazard description
Inaccurate test or measurement results
Product
Product name
Fore-Sight Elite Tissue Oximeter Module
Reference
ID
RA-63532