Events

Safety Alert for Digital System of Image by X-ray INNOVA 2000, 2100IQ, 3100, 4100, 2100IQ, 3100IQ, 4100IQ, Anvisa registry nº 80071260060 and Advantax Hemodynamic Equipment Monoplane Models LC +, LCV +, LCA +, registry Anvisa nº 80071260027.

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 Médico-Hospitalares 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
    915
  • Date
    2008-05-07
  • 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
    Attention: Should you experience a sudden drop in the tabletop and loss of vertical movement of your Omega table, contact your GEHC field engineer who will install a fix on your system. However, GE Healthcare recommends: I - Avoid procedures that could cause serious injury to the patient in case of sudden dropping of the table top (eg, procedures using stereotactic frames, needle punches, etc.); that there is a margin in the cables that are connected to the patient III - Do not place the patient's arms or any other objects below or on the side of the table top IV - Do not leave materials on the table that are likely to be damaged in case of fall the table.
  • Reason
    Certain omega iv and omega v tables may fall suddenly and quickly to their lowest position. this situation tends to occur during the vertical movement of the table. immediately after this situation, the vertical movement of the table is blocked. to date, no accident has occurred. currently, only eight of the more than 1,000 global facilities have been affected since july 2003. according to statistics, the likelihood of this problem occurring is low, since in about two million examinations, only eight problems were reported, and no injuries were reported. in such a situation, the system will remain operational, except for the vertical movement of the table. therefore, a procedure can be terminated in this degraded mode. here are some examples of procedures that may present some risk to the patient in the event of a sudden drop in the table: 1. procedures using cerebral stereotactic frames or involving needle punctures; 2. procedures involving the introduction and manipulation of a catheter into an artery; 3. procedures involving dilatation, as well as the use of stent or coil; 4. procedures in which the patient is lying face down on the table with his arms under the table top; 5. procedures in which accessories are placed on the tabletop. to visualize the international alert published by ecri, translated into portuguese, please go to: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_915_traduz .Pdf the charter developed by ge healthcare for its clients can be viewed at: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_915_carta.Pdf.
  • Action
    GE Healthcare has developed a technical correction to prevent incorrect table movement. This piece will need about an hour to install. This fix will be installed on-site at no additional cost to the customer and will be scheduled according to your availability. For questions or inquiries regarding this subject, please contact the Customer Service Center immediately on 0800 122 345.

Device

Digital System of Image by X-ray INNOVA 2000, 2100IQ, 3100, 4100, 2100IQ, 3100IQ, 4100IQ, Anvisa ...

Manufacturer

GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico-Hospitalares Ltda