Agency classClass IOur severity:Severe FDA (Devices)·Z-2029-2023·Announced 2023-07-12

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.

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 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
Category: Medical Device — Oximeter / Defibrillation Sensor
Hazard: defibrillation-failure
electrical-shock
measurement-error
Affected units: 5,039

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.

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 →

Same manufacturer · GE Healthcare Finland Oy

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Same hazard · defibrillation failure