GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Connection
GE Healthcare is recalling 3,319 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause loss of mechanical ventilation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (anesthesia system) where injury (hypoxia) has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
GE Healthcare, LLC is recalling 3,319 units of Carestation 620/650/650c A1 anesthesia systems. These devices are intended to provide general inhalation anesthesia and ventilatory support to pediatric and adult patients. The recall covers units distributed in the United States and numerous countries worldwide.
The recall was initiated because GE Healthcare became aware of a potential for a loose cable connection inside specific manufactured devices. This defect could cause a loss of mechanical ventilation. In such an event, the system will provide high-priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
Hospitals and healthcare facilities should identify affected units by checking the model number and serial numbers listed in the official recall notice. Clinicians should be aware of the potential for ventilation loss and monitor the high-priority alarms provided by the system.
The recalled product
- Product
- Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 3,319
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CARESTATION 620 A1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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