Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2008
  • Date
    2016-10-25
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA