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FDAMay 19, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ge healthcare finland oy

UPCs

00840682103220

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs — Recall Details · AllClear