TruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure
GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.
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 requires a minimum severity rating of Severe (4). The source reports no illnesses or injuries, which prevents a Critical rating despite the serious nature of the potential defibrillation and electrical hazards involved.
Plain-English summary
GE Healthcare Finland Oy is recalling 5,039 TruSignal Wrap Sensor oximeters (model REF TS-W-D, GTIN 00840682103121) distributed worldwide due to identified safety hazards.
The device has three potential defects: reduction of energy reaching the patient during defibrillation, potential contact with unintended electrical voltage, and inaccurate measurements. These issues could compromise critical monitoring and defibrillation functions in patient care settings.
The recall affects 5,039 units distributed globally. Healthcare facilities should be aware of these hazards associated with the affected devices.
The recalled product
- Product
- TruSignal Wrap Sensor, REF TS-W-D; Oximeter
- Manufacturer
- GE Healthcare Finland Oy
- Hazard
- defibrillation-failure
- electrical-shock
- 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 00840682103121
Distribution
Distribution scope not specified by the agency.
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