TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Reported: July 12, 2023 Initiated: May 19, 2023 #Z-2032-2023
Product Description
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
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
- 2707 units
- Distribution
- Worldwide
- Location
- Helsinki, N/A
Frequently Asked Questions
What product was recalled? ▼
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms). Recalled by GE Healthcare Finland Oy. Units affected: 2707 units.
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-2032-2023.
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