TruSignal adult and pediatric ear oximeter sensors recalled for voltage hazards
GE Healthcare's TruSignal Adult/Pediatric ear oximeter sensors are recalled worldwide due to potential reduction of defibrillation energy, risk of unintended electrical contact, and inaccurate oxygen measurement.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires a minimum severity score of 4 per regulatory guidelines. The identified hazards—potential reduction of defibrillation energy, unintended electrical contact, and measurement inaccuracy—represent significant risks to patient safety.
Plain-English summary
GE Healthcare Finland Oy has recalled 23,537 TruSignal Adult/Pediatric ear oximeter sensors worldwide. The recalled products include model REF TS-AP-10 (10-pack) and REF TS-AP-25 (25-pack), identified by GTIN 00840682103220.
The FDA has classified this as a Class I recall due to three potential safety hazards: reduction of energy reaching the patient during defibrillation, potential contact with unintended voltage, and inaccurate measurement of oxygen saturation levels. These hazards could affect the accuracy of patient monitoring and create electrical safety risks.
These sensors are used in healthcare settings to monitor patient oxygen levels. Healthcare facilities using these devices should verify their device model numbers and contact GE Healthcare, their healthcare provider, or facility biomedical engineering team for instructions on device inspection, replacement, or corrective action.
The recalled product
- Product
- TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Pulse Oximeter
- Affected units
- 23,537
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- a) REF TS-AP-10
- GTIN 00840682103220 b) REF TS-AP-25
- GTIN 00840682103220
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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