TruSignal Integrated Ear Sensor with Datex Connector recall
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Why was TruSignal Integrated Ear Sensor with Datex 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 00840682103428
- Product
- TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
- Recalling firm
- GE Healthcare Finland Oy
- Quantity
- 2707 units
- Distribution
- Worldwide
- Recall date
- July 12, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)