GE Healthcare, LLC recalls B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, an

Recalled December 19, 2018 · FDA recall Z-0587-2019 · GE Healthcare

Hazard

Patient monitors may restart due to network overload caused by network configuration. · FDA Class II

Units

5,516 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

B105/125 Patient Monitor. The device 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 intra-hospital transport.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →