July 31, 2023

FDA: Class I recall of GE HealthCare’s TruSignal SpO2 sensors

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious.

The recall was initiated because of issues that may reduce the amount of energy sent to the heart during defibrillation, unintentionally expose patients to electrical currents from other sources, or give inaccurate readings.

The company has not received any reports of injuries or deaths from this issue.

Distribution dates were January 1, 2021, to May 4, 2023.

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