Décision du 3 octobre 2001 relative à la suspension de mise sur le marché, de distribution et d'utilisation du matelas chauffant et du générateur associé, référence Micro 75-150, fabriqués par la société Klimamed Technologie Medizintechnik GmbH
Jurisdiction | France |
Publication au Gazette officiel | JORF n°249 du 26 octobre 2001 |
Enactment Date | 03 octobre 2001 |
Record Number | JORFTEXT000000225463 |
Court | MINISTERE DE L'EMPLOI ET DE LA SOLIDARITE |
Date de publication | 26 octobre 2001 |
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé,
Vu le code de la santé publique, et notamment les articles L. 5311-1 et L. 5312-1 ;
Vu la décision du 16 février 2001 relative à la suspension de mise sur le marché, de distribution et d'utilisation du matelas chauffant et du générateur associé, référence Micro 75-150, fabriqués par la société Klimamed Technologie Medizintechnik GmbH ;
Vu le courrier en date du 26 mars 2001, adressé au fabricant, lui demandant de faire réaliser par un laboratoire indépendant de son choix une expertise des deux matelas chauffants impliqués dans les deux incidents ;
Vu les résultats d'expertise transmis le 30 avril 2001 par le fabricant réalisée par le centre de recherche Forshungs und Transferzentrum e.V de l'institut d'enseignement supérieur de Zwickau ;
Vu le courrier en date du 23 juillet 2001, adressé au fabricant, lui demandant de faire réaliser des essais complémentaires se rapprochant des conditions réelles d'utilisation de ces matelas, selon un protocole d'expertise validé par l'AFSSAPS ;
Considérant que l'expertise des deux matelas, réalisée par le centre de recherche Forshungs und Transferzentrum e.V de l'institut d'enseignement supérieur de Zwickau, est très éloignée des conditions réelles d'utilisation de ces matelas, et qu'il convient en conséquence que le fabricant fasse procéder par un...
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