Recall Z-0814-2020— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-11-25, terminated 2023-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.. Reason: GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-11-25
- Terminated
- 2023-11-30
- Firm location
- Waukesha, WI, United States
Product description
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Reason for recall
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
Data sourced from openFDA. This site is unofficial and independent of the FDA.