FDA Recalls GE Healthcare Oximeter Sensors for Defibrillation and Electrical Hazards
GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.
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: This is classified FDA Class I, which establishes a minimum severity threshold of 4 (Severe). No deaths or serious injuries are reported in the source, so the score does not reach 5 (Critical). The hazards—defibrillation energy reduction and electrical contact risks—pose potential for serious patient harm.
Plain-English summary
The FDA issued a Class I recall of the TruSignal Sensitive Skin Sensor, model REF TS-SE-3, manufactured by GE Healthcare Finland Oy. The recall affects 2,097 units distributed worldwide.
This oximeter is used for patient monitoring in settings that may include defibrillation therapy. The recall addresses three potential hazards: reduced energy delivery during defibrillation, potential contact with unintended voltage, and inaccurate measurement readings.
These potential hazards carry risk of serious patient harm during critical care monitoring. The FDA's Class I classification indicates the highest level of regulatory concern, reserved for hazards that could result in serious injury or death if not corrected.
Healthcare facilities and providers are advised to verify whether affected units are in use and to contact GE Healthcare Finland Oy or the FDA for further guidance regarding the recalled devices.
The recalled product
- Product
- TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Oximeter
- Affected units
- 2,097
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 00840682103282
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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