GE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards
GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.
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 classification mandates a minimum severity score of 4. The potential hazards involve critical patient safety functions including defibrillation delivery and patient monitoring.
Plain-English summary
GE Healthcare Finland Oy is recalling the TruSignal Ear Sensor, REF TS-E-D (an oximeter), distributed worldwide. The recall involves approximately 10,451 devices.
The recall addresses three potential hazards: (1) potential reduction of energy reaching the patient during defibrillation, which could impact emergency resuscitation efforts; (2) potential contact with unintended voltage, creating an electrical safety risk; and (3) inaccurate measurement readings that could affect clinical decision-making.
Healthcare facilities and users of this sensor should contact GE Healthcare Finland Oy or the FDA for information regarding the recall.
The recalled product
- Product
- TruSignal Ear Sensor, REF TS-E-D; Oximeter
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Oximeter
- Affected units
- 10,451
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 00840682103251
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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