Ear oximeter sensor recalled for defibrillation and voltage safety concerns
GE Healthcare is recalling 512 TruSignal ear oximeter sensors worldwide due to potential defibrillation energy loss, unintended voltage exposure, and measurement inaccuracy risks.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. The potential hazards—defibrillation energy loss, unintended electrical voltage exposure, and measurement inaccuracy—could affect patient safety, though no illnesses or injuries have been explicitly reported in this notice.
Plain-English summary
GE Healthcare Finland Oy is recalling 512 TruSignal Integrated Ear Sensor devices with GE Connector (REF TS-E2-GE) worldwide. These devices are oximeter sensors used for monitoring oxygen saturation levels.
The FDA has classified this as a Class I recall due to three potential safety hazards. The sensors may fail to deliver adequate energy levels during defibrillation, users may be exposed to unintended electrical voltage, and the devices may provide inaccurate measurement readings in patient monitoring.
Hospitals and healthcare facilities currently using these devices should contact GE Healthcare Finland Oy for information regarding recall response, including device replacement or repair options.
The recalled product
- Product
- TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Ear Oximeter
- Affected units
- 512
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 (1)
- GTIN 00840682103138
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.
See all 9 products in this recall →Related recalls
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