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.
Reason for recall: 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. Distribution: 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 Zealan Quantity: 2,642 units (1037 units US; 1605 units OUS) Lot/code info: Lot Code: Model Horizon A; UDI 15420045505384 Model Horizon C; UDI 15420045505698 Model Horizon CI; UDI 15420045505827 Model Horizon W; UDI 15420045505834 Model Horizon WI; UDI15420045505865. *****UPDATE 8/16/24*** US Serial Numbers: 305588M 305953M 305958M 305959M 305964M 305967M 305968M 305969M 305985M 305986M 305987M 305988M 305989M 305990M 305991M 305994M 305997M 305998M 305999M 306000M 306001M 306002M 306004M 306005M 306006M 306007M 306020M 306021M 306022M 306023M 306024M 306025M 306026M 306027M 306028M 306048M 306050M 306051M 306052M 306053M 306054M 306055M 306076M 306077M 306078M 306080M 306081M 306083M 306086M 306087M 306092M 306093M 306097M 306107M 306108M 306110M 306111M 306114M 306116M 306117M 306118M 306119M 306120M 306121M 306122M 306125M 306126M 306127M 306128M 306129M 306136M 306143M 306144M 306145M 306146M 306147M 306148M 306169M 306171M 306172M 306173M 306174M 306175M 306176M 306177M 306180M 306182M 306183M 306184M 306185M 306185M 306186M 306188M 306189M 306190M 306191M 306192M 306193M 306194M 306218M 306223M 306224M 306225M 306235M 306237M 306240M 306241M 306242M 306244M 306250M 306251M 306253M 306254M 306255M 306258M 306259M 306260M 306261M 306262M 306263M 306264M 306270M 306272M 306273M 306274M 306278M 306279M 306283M 306289M 306290M 306291M 306292M 306293M 306294M 306295M 306296M 306297M 306298M 306300M 306314M 306319M 306320M 306323M 306330M 306331M 306332M 306333M 306336M 306337M 306338M 306339M 306340M 306341M 306343M 306344M 306345M 306346M 306353M 30
15420045505384, 15420045505698, 15420045505827, 15420045505834
Official record: FDA (Device enforcement) ↗
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