Z-2034-2023 Class I Ongoing
FDA device recall Z-2034-2023 was initiated by GE Healthcare Finland Oy on May 19, 2023 and is designated Class I. Reason for recall: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. The recall status is ongoing. Affected quantity: 237 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 devices
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.
Distribution Pattern
Worldwide
Code Information
GTIN 00840682103367