Device product
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Z-0769-2016
Product summary
- Event
- Event 72974
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126
- Official record key
device-enforcement:Z-0769-2016
Official wording
Reason: 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.
Code information: Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.