Events

Safety Alert for Trade name: E.CAM Signature Series Brand Siemens; SPECT System Technical Name: Camile Cintilografica; Nuclear Imaging System ANVISA registration number: 10234230040; 10345161991 Risk Class: III; II Affected Model: E.CAM Siganture Series, brand SIEMENS; Symbia E, Symbia S Series numbers affected: 3097, 8019, 8011, 5626, 7016, 7507, 7507, 7006, 3072, 2016, 3051, 4019, 4022, 1007, 4102, 5028, 4091, 4124, 4192, 7552, 861, 8797, 7546, 1086, 1126, 1093, 1066, 1033, 1040, 1051, 1031, 1056, 1047, 1084, 3002, 3006, 4004, 3003, 4042, 11194, 11463, 9029, 11048, 9002, 11073, 9036, 1367, 1115, 1161, 1267, 1371, 1241, 1358, 1368, 1050, 1113, 1372, 1366, 1111, 1169.

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. Molecular Imaging..

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
    2085
  • Date
    2016-11-11
  • 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 system instructions.
  • Reason
    Siemens healthcare advises that patient positioning instructions must be adhered to so patients' hair is not trapped in the patient bed rise / fall units.
  • Action
    Field Action Code MI010 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in Field.

Device

Trade name: E.CAM Signature Series Brand Siemens; SPECT System Technical Name: Camile Cintilograf...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc. Molecular Imaging.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA