FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction
GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.
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 recall as classified by the agency, which indicates a serious device malfunction that may cause harm. Although no illnesses or injuries have been reported, the potential for defibrillation energy loss and unintended voltage exposure creates significant patient risk.
Plain-English summary
GE Healthcare Finland Oy is recalling 36,337 TruSignal AllFit Sensor oximeters (models REF TS-AF-10 and REF AF-25) distributed worldwide. The FDA has classified this as a Class I recall.
The sensors may experience potential reduction of energy reaching the patient during defibrillation, potential contact with unintended voltage, or provide inaccurate measurements. These defects may affect patient safety during cardiac monitoring and treatment.
No illnesses or injuries have been reported. If you are using affected devices, contact your healthcare provider or GE Healthcare for replacement or return instructions.
The recalled product
- Product
- TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Pulse Oximeter
- Affected units
- 36,337
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 (3)
- a) REF TS-AF-10
- GTIN 0840682103176 b) REF TS-AF-25
- GTIN 0840682103176
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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