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Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,
Recalled July 24, 2024 · FDA recall Z-2373-2024 · Hologic
Hazard
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability. · FDA Class II
Units
2,642 units (1037 units US; 1605 units OUS)
Sold at
Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, Andorra, Switzerland, Taiwan, Austria, Korea, Republic of Philippines, Kuwait, Slovakia, China, Belgium, Ireland, United Kingdom, Malaysia, Palestinian Territory, Occupied, Peru, Singapore, Qatar, Algeria, Pakistan, New Zealand, Croatia, Brazil, Bangladesh, Saudi Arabia, Venezuela, Israel, Lebanon, Nepal, Romania, Greece, Hong Kong, Morocco, Indonesia, Cyprus, Jordan, France, Mexico, Colombia, Iran, Islamic, Republic of Chile, Turkey, Uruguay, Viet Nam, Serbia, Poland, Japan, Malta, Netherlands, South Africa.
Description
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
Product
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
Manufacturer(s)
Hologic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →