Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant des syst\u00e8mes d\u2019\u00e9chographie diagnostique Lumify de Philips Ultrasound. L\u2019alerte vise plusieurs versions logicielles de l\u2019application Lumify sur iOS et Android, associ\u00e9es \u00e0 diff\u00e9rents identifiants UDI-DI (GTIN), utilis\u00e9es avec des sondes d\u2019\u00e9chographie connect\u00e9es.<\/p>\n
Selon Philips Ultrasound, un d\u00e9faut logiciel de l\u2019application Lumify (Android ou iOS) peut emp\u00eacher la reconnaissance d\u2019une sonde pr\u00e9alablement enregistr\u00e9e. Sans pr\u00e9avis, l\u2019application peut exiger une nouvelle proc\u00e9dure d\u2019enregistrement avant l\u2019utilisation au point de soins, bloquant toute fonction de scan tant que cette \u00e9tape n\u2019est pas r\u00e9alis\u00e9e. Cette r\u00e9inscription n\u00e9cessite l\u2019acc\u00e8s \u00e0 un r\u00e9seau Wi-Fi ou cellulaire. Les dispositifs utilis\u00e9s en dehors de l\u2019h\u00f4pital (ambulances, a\u00e9ronefs, interventions de terrain) sont jug\u00e9s particuli\u00e8rement \u00e0 risque en raison de l\u2019acc\u00e8s limit\u00e9 aux r\u00e9seaux. Philips signale avoir re\u00e7u des rapports d\u2019\u00e9v\u00e9nements o\u00f9 cette r\u00e9inscription impr\u00e9vue a emp\u00each\u00e9 la r\u00e9alisation d\u2019\u00e9chographies en pr\u00e9hospitalier et retard\u00e9 la prise en charge des patients, dans des environnements d\u00e9pourvus de connexion.<\/p>\n
Le 24 septembre 2026, Philips Ultrasound a adress\u00e9 un courrier \u00e0 l\u2019ensemble des clients concern\u00e9s avec des recommandations op\u00e9rationnelles. Il est demand\u00e9 de n\u2019utiliser le syst\u00e8me Lumify que dans des zones disposant d\u2019un acc\u00e8s Wi-Fi ou cellulaire facilement disponible, sauf si un dispositif d\u2019\u00e9chographie de secours est imm\u00e9diatement accessible. Philips recommande \u00e9galement de disposer syst\u00e9matiquement de dispositifs ou modalit\u00e9s d\u2019imagerie de secours pour assurer la continuit\u00e9 des soins, de diffuser le courrier d\u2019information \u00e0 tous les utilisateurs du dispositif, d\u2019afficher l\u2019avis pr\u00e8s des unit\u00e9s concern\u00e9es et de consulter r\u00e9guli\u00e8rement la page d\u00e9di\u00e9e de la FDA pour suivre les mises \u00e0 jour.<\/p>\n
La FDA indique \u00eatre en cours d\u2019examen de ce probl\u00e8me de dispositif \u00e0 haut risque potentiel et annonce qu\u2019elle actualisera les informations publiques en fonction de l\u2019\u00e9volution des donn\u00e9es. Philips pr\u00e9cise \u00eatre en train de d\u00e9velopper une mise \u00e0 jour logicielle destin\u00e9e \u00e0 corriger le probl\u00e8me de r\u00e9enregistrement. L\u2019ensemble de ces \u00e9l\u00e9ments pr\u00e9sente un enjeu de s\u00e9curit\u00e9 des soins, en particulier pour la prise en charge pr\u00e9hospitali\u00e8re et en milieu isol\u00e9, et illustre le r\u00f4le des autorit\u00e9s de r\u00e9gulation (FDA) et des fabricants (Philips Ultrasound) dans la surveillance et la gestion des risques li\u00e9s aux dispositifs m\u00e9dicaux num\u00e9riques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant des […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-20462","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20462","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20462"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20462\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20462"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20462"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}