Retiro De Equipo (Recall) de Device Recall Octopus 900

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Haag-Streit USA Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60631
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0638-2012
  • Fecha de inicio del evento
    2011-11-14
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Instrument, measuring, corneal radius - Product Code HJB
  • Causa
    Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. if no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.
  • Acción
    Haag-Streit USA Inc sent an Urgent Field Safety Notice letter dated November 11, 2011 to their customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to check their unit and if needed upgrade their unit with the new software provided. Customers were advised to complete and return the Software Update Verification Form included. Customers who had distributed the affected product outside of their facility were instructed to immediately notify their customers of the recall.

Device

  • Modelo / Serial
    Model Number: Octopus 900, S/N's: 159, 231, 279, 313, 314, 315, 336, 338, 478, 479, 484, 485, 559, 560,561, 562, 563, 642, 644, 645, 646, 647, 648, 649, 650, 651, 772, 773, 774, 775, 776, 777, 797, 798, 804, 805, 806, 807, 808, 813, 814, 839, 840, 841, 842, 843, 844, 868, 869, 870, 871, 872, 873, 874, 903, 904, 905, 907, 908, 909, 910, 911, 956, 957, 958, 959, 975, 983, 984, 985, 986, 987, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1034, 1035, 1036, 1037, 1038, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1117, 1118, 1119, 1120, 1140, 1141, 1143, 1152, 1162, 1163, 1164, 1166, 1199, 1200, 1201, 1202, 1239, 1240, 1241, 1262, 1263, 1286, 1287, 1288, 1307, 1308, 1401, 1402, 1403, 1404, 1405, 1424, 1425, 1426, 1458, 1459, 1460, 1480, 1481, 1482, 1483, 1484, 1543, 1545, 1546, 1550, 1552, 1553, 1554, 1555, 1556, 1560, 1561, 1562, 1563, 1564, 1579, 1580, 1581, 1582, 1583, 1586, 1587, 1588, 1589 and 1591.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA and WA and the country of Mexico.
  • Descripción del producto
    Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 || Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA