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Fore-sight elite tissue oximeter module
Official notice
9 May 2022
Last checked
9 May 2022
An official Health Canada notice concerns Fore-sight elite tissue oximeter module. 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 Published 2022-05-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63532
Official notice
2022-05-09
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Edwards Lifesciences, Fore-sight Elite Tissue Oximeter Module.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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