The Recall Desk
SevereFDA (Devices)·Z-2030-2023·Announced 2023-07-12

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.

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 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
Hazard
  • electrical-hazard
  • defibrillation-failure
  • measurement-error

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.

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