FDAClass IJuly 12, 2023

TruSignal Integrated Ear Sensor with Ohmeda Connector recall

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

Why was TruSignal Integrated Ear Sensor with Ohmeda Connector recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 00840682103367

Product
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Recalling firm
GE Healthcare Finland Oy
Quantity
237 devices
Distribution
Worldwide
Recall date
July 12, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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