Z-2028-2023 Class I Ongoing
FDA device recall Z-2028-2023 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: 2097 units.
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
- 2097 units
Product Description
TruSignal Sensitive Skin Sensor, REF TS-SE-3; 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 00840682103282