FDA identifies GE HealthCare recall of sensors for defibrillators as class I
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Key takeaways:
- GE HealthCare recalled its SpO2 sensors due to a malfunction that may reduce defibrillation energy without notification to the care provider.
- The FDA has identified the recall as class I, the most serious type.
GE HealthCare announced a recall of arterial oxygen saturation sensors due to a malfunction that may reduce the amount of energy sent to the heart during defibrillation without notification to the care provider.
If the sensors (TruSignal) malfunction, that could prevent delivery of lifesaving therapy and is most hazardous to patients who are hospitalized and may need defibrillation for cardiac arrest, according to an FDA press release.
Image: Adobe Stock
Additionally, malfunctioning sensors may also expose patients to electrical currents from other sources or provide inaccurate arterial oxygen saturation (SpO2) measurements, according to the release.
The FDA has identified this recall as class I, the most serious type, a use of the defective SpO2 sensors may cause serious injury or death.
The recall includes 7,559 SpO2 sensors distributed between Jan, 1, 2021, and March 4, 2023.
The company reported no injuries or deaths related to this issue.
GE HealthCare sent the following statement by email to Healio:
“Patient safety is our top priority. We are informing customers of the potential issue and providing them with interim instructions until the affected products are replaced. There are no reports of patient injury as a result of this issue.”
Editor’s Note: This article was updated on July 28, 2023 to reflect an update to the FDA alert about the number of injuries associated with the recall, and to add the statement from GE HealthCare.
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