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GE Healthcare, LLC recalls PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter un
Recalled December 19, 2018 · FDA recall Z-0583-2019 · GE Healthcare
Hazard
Patient monitors may restart due to network overload caused by network configuration. · FDA Class II
Units
28,004 patient monitors
Sold at
Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Brunei, Bulgaria, Burma (Myanmar), Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kampuchea, Kazakstan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Zambia.
Description
Patient monitors may restart due to network overload caused by network configuration.
Product
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →