Events

Alerte De Sécurité sur Two products are affected by the action of Field: 1. Trade Name: E.CAM SIGNATURE SERIES MARK SIEMENS - Technical Name: Camile Cintilografica (Gamma Camera) - Registration 10234230040 - Model: E.CAM Signature Series, brand SIEMENS /// 2. Trade name: SISTEMA SPECT - Registro 10345161991 - Model: Symbia E - Technical name: Nuclear Imaging System - ANVISA registration number: 80004040126 /// Number of series affected: 3002; 3003; 3006; 4004; 1086; 1093; 1126; 1007; 2016; 3051; 3072; 4019; 4022; 4091; 4102; 4124; 4192; 5017; 5028; 4042; 4091; 7546; 7552; 8671; 8797; 8019; 5626; 7016; 7006; 7507; 550; 588; 3097; 11194; 11463; 10012; 11048; 11073; 9002; 9036; 9029; 1031; ; 1033; 1040; 1047; 1051; 1056; 1066; 1084; 1085; 1050; 1111; 1113; 1115; 1161; 1169; 1241; 1267; 1334; 1358; 1366; 1367; 1368; 1371; 1372; 1157; 1166; 1173; 1194; 1210; 1231; 1259; ; 1267; 1303; 1314; 1318; 1355; 1383; 1391; 1403; 1404; 1406; 1678; 1681; 1682; 1032.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2008
  • Date
    2016-10-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Siemens recommends a re-examination of the "Safety" section of the user manual with the establishment's employees and make sure that this warning is included in the instructions for use of the system.
  • Cause
    If the patient is positioned incorrectly and is unaccompanied during the examination, it is possible for their hair to be trapped in the patient bed unit's uphill / descent unit of the e.Cam and symbia e.
  • Action
    Field Action No. MI009 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company issued a Letter to Customers stating that patient positioning instructions must be respected so that patients' hair is not trapped in the patient's up / down units. patient bed

Device

Two products are affected by the action of Field: 1. Trade Name: E.CAM SIGNATURE SERIES MARK SIEM...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA