FDAFDA · Alimentos y medicamentos·N.º oficial Z-2373-2024
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
Publicado el 24 de julio de 2024 · Inicio del retiro: 13 de junio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hologic Inc
- Distribuidor
- 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.
- Lote
- 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 306365M 306368M 306369M 306372M 306373M 306375M 306381M 306386M 306387M 306388M 306389M 306390M 306392M 306393M 306394M 306395M 306396M 306397M 306398M 306400M 306403M 306404M 306405M 306406M 306407M 306413M 306416M 306417M 306420M 306421M 306425M 306427M 306429M 306439M 306440M 306441M 306442M 306443M 306446M 306449M 306450M 306451M 306452M 306453M 306454M 306463M 306465M 306466M 306467M 306468M 306469M 306470M 306471M 306475M 306477M 306478M 306479M 306480M 306481M 306482M 306484M 306485M 306498M 306502M 306506M 306506M 306507M 306508M 306512M 306513M 306515M 306516M 306517M 306518M 306519M 306521M 306523M 306524M 306526M 306527M 306528M 306530M 306531M 306534M 306535M 306537M 306539M 306542M 306555M 306556M 306558M 306560M 306563M 306564M 306565M 306567M 306569M 306570M 306571M 306572M 306573M 306574M 306575M 306578M 306589M 306590M 306592M 306593M 306594M 306618M 306619M 306621M 306622M 306623M 306625M 306626M 306627M 306628M 306629M 306630M 306631M 306632M 306633M 306634M 306636M 306637M 306638M 306640M 306641M 306642M 306643M 306664M 306665M 306667M 306668M 306669M 306669M 306671M 306672M 306679M 306680M 306682M 306683M 306684M 306686M 306687M 306688M 306689M 306690M 306691M 306692M 306693M 306694M 306695M 306696M 306697M 306698M 306699M 306701M 306702M 306702M 306703M 306704M 306705M 306706M 306707M 306708M 306709M 306710M 306711M 306712M 306715M 306716M 306717M 306718M 306719M 306720M 306721M 306722M 306725M 306726M 306727M 306729M 306731M 306733M 306734M 306734M 306736M 306737M 306738M 306742M 306747M 306765M 306768M 306772M 306779M 306780M 306781M 306817M 306818M 306819M 306820M 306821M 306822M 306823M 306824M 306828M 306829M 306830M 306831M 306832M 306834M 306835M 306841M 306849M 306853M 306857M 306861M 306865M 306868M 306871M 306872M 306874M 306875M 306876M 306877M 306878M 306881M 306883M 306888M 306892M 306896M 306899M 306900M 306901M 306902M 306903M 306904M 306905M 306906M 306907M 306909M 306910M 306913M 306914M 306916M 306918M 306920M 306921M 306922M 306923M 306924M 306959M 306961M 306962M 306964M 306966M 306968M 306970M 306972M 306974M 306983M 306984M 306987M 306988M 306989M 306990M 306993M 306995M 306996M 306997M 306998M 306999M 307000M 307001M 307002M 307005M 307006M 307007M 307008M 307010M 307042M 307044M 307045M 307046M 307048M 307050M 307051M 307053M 307054M 307056M 307057M 307058M 307060M 307061M 307062M 307064M 307065M 307066M 307067M 307068M 307070M 307071M 307072M 307073M 307074M 307075M 307076M 307077M 307078M 307079M 307086M 3070
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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