Critical RiskFDA Device

GE Healthcare Finland Oy: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Agency Publication Date: July 7, 2023

Affected Products

Product: TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

a) REF TS-AP-10, GTIN 00840682103220 b) REF TS-AP-25, GTIN 00840682103220

Product: TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176

Product: TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

GTIN 00840682103282

Product: TruSignal Wrap Sensor, REF TS-W-D; Oximeter

GTIN 00840682103121

Product: TruSignal Ear Sensor, REF TS-E-D; Oximeter

GTIN 00840682103251

Product: TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

GTIN 00840682103138

Product: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

GTIN 00840682103428

Product: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

GTIN 00840682103381

Product: TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

GTIN 00840682103367

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92455

Status: Active

Manufacturer: GE Healthcare Finland Oy

Manufactured In: Finland

Units Affected: 9 products (23537 devices; 36337 devices; 2097 units; 5039 units; 10451 devices; 512 devices; 2707 units; 708 devices; 237 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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