Events

Alerte De Sécurité sur 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.

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 GE Healthcare do Brasil; GE Medical Systems, LLC.

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
    1537
  • Date
    2015-03-12
  • 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
    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.
  • Cause
    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