GE Healthcare, LLC recalls Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and…

Recall date

November 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0814-2020

FDA classification

Class I

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guate…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.