PlainRecalls
FDA Devices Critical Class I Ongoing

TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

Reported: July 12, 2023 Initiated: May 19, 2023 #Z-2034-2023

Product Description

TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

Reason for Recall

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Details

Recalling Firm
GE Healthcare Finland Oy
Units Affected
237 devices
Distribution
Worldwide
Location
Helsinki, N/A

Frequently Asked Questions

What product was recalled?
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter. Recalled by GE Healthcare Finland Oy. Units affected: 237 devices.
Why was this product recalled?
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 12, 2023. Severity: Critical. Recall number: Z-2034-2023.