A specific component was the wrong choice or failed in the field. The FDA lists 54 recalls with this root cause since 2025, 10 of them Class I (most serious). Most recent report: Oct 7, 2026.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result.…
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone resul…
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result…
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators;…
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.…
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.