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GE Medical Systems, LLC recalls GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic i
Recalled February 17, 2016 · FDA recall Z-0769-2016 · GE Medical Systems
Hazard
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. · FDA Class II
Units
126
Sold at
Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Description
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
Product
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →