Events

Alerta De Seguridad para Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD20 Ceiling / Allura Xper FD20 Floor / Allura Xper FD10 OR Table / Allura Xper FD20 OR Table Affected serial numbers: 566, 538, 869, 737, 1108, 1124, 1277, 1308, 2415, 1568, 1569, 1570, 1639, 1620, 1593, 2817, 1726, 1751, 538; SN; 869; 737; 1108; 1124; 1277; 1308; 2415; 1568; 1569; 1570; 1639; 1620; 1593; 2817; 1726; 1751; 1743; 1702; 1802; 1255/1; 00051432; 1224; 1113; 1861; 2043; 2117; 2173; 2389; 45; 53; 91; 92; 123; 173; 174; 195; 176; 187; 289; 248; 134; 230; 302; 232; 323; 370; 231; 402; 405; 245; 502; 508; 509; 535; 537; 553; 575; 602; 619; 712; 713; 825; 941; 948; 991; 1001; 1093; 1124; 1137; 1148; 1197; 1199; 1304; 1307; 1326; 1339; 1346; 1351; 109; 139; 170; 180; 263; 350; 347; 550; 628; 664; 759; 795; 809; 914; 2107; 1156; 1291; 1376; 1460; 1464; 1865; 1872; 1971; 2314; 2335; 2350; 2352; 2406; 444; 589; 25; 47; 137; 285; 306; 308; 322; 379; 565; 700; 737; 763; 87; 154.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems Nederland BV. / Dixtal Biomédica Indústria e Comércio Ltda / Philips Medical Systems Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2252
  • Fecha
    2017-03-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Inform your team of potential danger. No additional measures, other than pre-set institutional procedures to manage potential fire hazards, are considered necessary. If a fire, smoke, or fire odor is detected from the technical space, the main switch must be turned off and the system removed from service immediately. The institution's emergency procedures for such events should be followed. Once the risk situation has been reduced, your local Philips representative should be advised.
  • Causa
    Philips has discovered, through customer complaints, a problem with the detector's cooling system. due to a leak in the refrigerant system of the detector, the coolant may leak out of the refrigerator drip tray. if this occurs, liquid may drip into the electrical components in the r-cabin located in the technical space, which could result in damage to the system and potentially cause thermal events such as combustion, smoke or fire odor.
  • Acción
    Field Action Code FCO72200384 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland BV. / Dixtal Biomédica Indústria...
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA