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.
Reported: January 29, 2020 Initiated: November 25, 2019 #Z-0814-2020
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 280 units
- Distribution
- 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, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
- Location
- Waukesha, WI
Frequently Asked Questions
What product 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.. Recalled by GE Healthcare, LLC. Units affected: 280 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Critical. Recall number: Z-0814-2020.
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