Events

Safety Alert for Nuclear Imaging System, Models: Millennium VG and Discovery VH, Record: 10310650051, Risk class III, Affected serial numbers: All model configurations .///. Gamma Camera for Nuclear Medicine Apex-VariCam, Model: APEX-VARICAM, Record: 10306980014, Serial numbers affected: All model settings.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; GE Medical Systems, LLC.

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
    1537
  • Date
    2015-03-12
  • 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
    According to company information the products affected by this field action are not at risk unless the collimator nuts have been loosely loosened during a maintenance intervention. This loosening of the nuts without a proper re-tightening is considered a technical error of the service provider. In case of collimator fall, there is possibility of permanent damage or fatal injury. However, to date, reports of adverse events have no record of collimator / injury falls during clinical use of the equipment.
  • Reason
    During the quality control check, a collimator of the vg system collapsed while the detectors were in rotation. there is no record of collimator fall during clinical use of the equipment.
  • Action
    It is company guidelines that the operator should monitor the patient and the system throughout the scan procedure. In case of collimator detachment, pull the Table Patient Release Handle to remove the patient as indicated in the User Manual. If difficulties or errors arise with the collimator exchange procedure, the operator's manual informs the "collimator change" in the chapter on safety and regulatory information, stating that: "the collimators must be installed properly and secured firmly. Every time after mounting a new collimator set on the head and before performing a scan, rotate the gantry in full rotation (360 °) at least without a patient on the table to check that the collimators are firmly anchored in place ... ". If you have any questions, please contact GE Technical Assistance. /// Attempt to use the most up-to-date version of the Service Manual and Preventive Maintenance procedure (see link: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library). //// GE Healthcare Technical Assistance will inspect all affected systems to verify that the collimator trolleys and locking mechanisms are operating safely and meet all specifications.

Device

Nuclear Imaging System, Models: Millennium VG and Discovery VH, Record: 10310650051, Risk class I...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems, LLC