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GE Healthcare, LLC recalls CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumat
Recalled September 2, 2020 · FDA recall Z-2883-2020 · GE Healthcare
Hazard
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered. · FDA Class II
Units
2277 units
Sold at
Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.
Description
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Product
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →