Health product recall

GE Healthcare TruSignal™ SpO₂ Sensors

Last updated

Summary

Product
GE Healthcare TruSignal™ SpO₂ Sensors
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Sensitive Skin Disposable Sensor Contact the manufacturer. TS-SE-3 TS-W-D
AllFit Disposable Sensor Contact the manufacturer. TS-AF-10 TS-AF-25
Integrated Ear Sensors Contact the manufacturer. TS-E-D TS-E4-GE TS-E2-GE TS-E4-N TS-E4-H
Adult/Ped Disposable Sensor Contact the manufacturer. TS-AP-10 TS-AP-25

Issue

Potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement related to TrusignalTM SpO2 sensors.

Recall start date: June 5, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - General and plastic surgery
Companies

GE Healthcare Finland Oy

Kuortaneenkatu 2, Helsinki, Finland, 00510

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73860