Z-2026-2023 Class I Ongoing
FDA device recall Z-2026-2023 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: 23537 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
- 23537 devices
Product Description
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
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
a) REF TS-AP-10, GTIN 00840682103220 b) REF TS-AP-25, GTIN 00840682103220