Events

Safety Alert for All Infinia nuclear medicine systems manufactured between 2003 - 2014: • Infinia //// • Infinia e-Hawkeye 4 //// • All Brivo NM615, Discovery NM630, Optima NM / CT640 and Discovery NM / CT670 systems. . The products affected by the Field Action are registered in Brazil as follows: (1) .Brivo NM 615 - 80071260136; (2). Discovery NM 630-80071260136; (3). Optima NM / CT640-80071260239; (4). Discovery NM / CT670-80071260122; (5). Infinia - 80071260049; (6). Infinia Hawkeye 4 - 80071260086 ## (MAP OF DISTRIBUTION IN ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS MEDICO-HOSPITALARES LTDA (General Electric); GE MEDICAL SYSTEMS FUNCTIONAL IMAGING HALFA D/B/A ELGEMS LTDA..

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
    1428
  • Date
    2014-09-26
  • 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
    RECOMMENDATIONS OF THE REGISTERING COMPANY: "Owners must wait for the additional Preventive Maintenance check related to loose fasteners in Nuclear Medicine systems. Users should also confirm that the organization that provides technical assistance to their equipment uses the latest version of the Manual and the Preventive Maintenance procedure The latest versions of the Service Manual and the Preventive Maintenance procedure are available on the Internet at: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation + Library Verification instructions are detailed in the "Product Correction" field of the communication letter to customers. "
  • Reason
    Possibility of a part of the system falling on the patient during a scan procedure. according to the product registration holder in brazil, "ge healthcare recently conducted a field action (ref. fmi 40849) related to its nuclear medicine system due to a potential safety problem related to the possibility of a part of the system over a patient during a scan procedure, because the fasteners holding the camera in the gantry are loose. a failure of the fasteners may cause a nuclear medicine detector to fall, with the possibility of having a direct impact on a patient or operator. ".
  • Action
    Company has triggered field action of "Field Correction to Verify Camera Fixers and Correction if Necessary.". Code: IMF 40860 (URGENT SAFETY WARNING IN ANNEX)

Device

All Infinia nuclear medicine systems manufactured between 2003 - 2014: • Infinia //// • Infinia e...

Manufacturer

GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS MEDICO-HOSPITALARES LTDA (General E...