Retiro De Equipo (Recall) de OPERON D850 Surgical Table

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 Berchtold Corp..

¿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
    65960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2168-2013
  • Fecha de inicio del evento
    2012-04-16
  • Fecha de publicación del evento
    2013-09-09
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-09-10
  • 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
    Table, operating-room, electrical - Product Code GDC
  • Causa
    Table was not lowering.
  • Acción
    Berchtold sent a Customer Notification letter dated April 16, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that BERCHTOLD will upgrade the OPERON Surgical tables with a new firmware version that will eliminate the potential for experiencing problems. For questions call 843-569-6100 ext. 322.

Device

  • Modelo / Serial
    3501110-S10023, 3501110-S10024, 3501110-S10025, 3501110-S10205, 3501110-S10208, 3501110-S10064, 3501110-S10036, 3501110-S10043, 3501110-S10045, 3501110-S10050, 3501110-S10061, 3501110-S10062, 3511110-S10139, 3511110-S10143, 3511110-S10144, 3511110-S10162, 3501110-S10192, 3501110-S10018, 3511110-S10038, 3511110-S10041, 3511110-S10047, 3511110-S10072, 3511110-S10137, 3511110-S10138, 3501110-S10153, 3501110-S10166, 3501110-S10093, 3501110-S10104, 3501110-S10090, 3501110-S10147, 3501110-S10262, 3501110-S10281, 3501110-S10105, 3501110-S10172, 3501110-S10195, 3501110-S10109, 3501110-S10134, 3501110-S10099, 3501110-S10101, 3501110-S10151, 3511110-S10086, 3511110-S10092, 3511110-S10085, 3511110-S10091, 3501110-S10065, 3501110-S10037, 3501110-S10056, 3501110-S10259, 3501110-S10083, 3501110-S10170, 3501110-S10212, 3501110-S10067, 3501110-S10073, 3501110-S10116, 3501110-S10117, 3501110-S10119, 3501110-S10157, 3501110-S10167, 3501110-S10204, 3501110-S10207, 3501110S-10110, 3511110-S10234, 3501110-S10078, 3501110-S10034, 3501110-S10035, 3501110-S10097, 3501110-S10112, 3501110-S10088, 3501110-S10096, 3501110-S10098, 3501110-S10102, 3501110-S10111, 3501110-S10019, 3501110-S10021, 3501110-S10022, 3501110-S10223, 3501110-S10267, 3501110-S10049, 3501110-S10044, 3501110-S10052, 3501110-S10149, 3501110-S10121, 3501110-S10129, 3501110-S10254, 3501110-S10257, 3501110-S10263, 3501110-S10100, 3511110-S10176, 3511110-S10221, 3501110-S10026, 3501110-S10051, 3501110-S10211, 3501110-S10251, 3501110-S10046, 3501110-S10053, 3501110-S10054, 3501110-S10055, 3501110-S10063, 3501110-S10080, 3501110-S10028, 3501110-S10027, 3501110-S10027, 3501110-S10152, 3511110-S10161, 3501110-S10079, 3501110-S10095, 3511110-S10039, 3501110-S10103, 3501110-S10209, 3501110-S10213, 3501110-S10076, 3501110-S10114, 350110-S10118, 3501110-S10126, 3501110-S10128, 3501110-S10136, 3501110-S10154, 3501110-S10156, 3501110-S10158, 3501110-S10258, 3501110-S10249, 3501110-S10256, 3501110-S10260, 3501110-S10261, 3501110-S10031, 3501110-S10210, 3501110-S10277, 3501110-S10070, 3501110-10082, 35011100-S10084, 3501110-S10087, 3501110-S10089, 3501110-S10248, 3501110-S10250, 3501110-S10131, 3501110-S10094, 3501110-S10016, 3501110-S10017, 3501110-S10020, 3501110-S10030, 3501110-S10206, 3501110-S10252, 3501110-S10148, 3501110-S10155, 3501110-S10171, 3501110-S10173, 3511110-S10107, 3501110-S10193, 35011110-S10233, 3511110-S10159, 3511110-S10160, 3511110-S10168, 3511110-S10169, 3511110-S10181, 3511110-S10196, 3511110-S10197, 3511110-S10198, 3511110-S10199, 3511110-S10200, 3511110-S10201, 3511110-S10202, 3511110-S10214, 3511110-S10215, 3511110-S10218, 3511110-S10219, 3511110-S10228, 3511110-S10235, 3501110-S10253, 3501110-S10255, 3511110-S10033, 3501110-S10074, 3501110-S10075, 3501110-S10077, 3511110-S10040, 3511110-S10145, 3511110-S10032, 3501110-S10270, 3501110-S10135, 3501110-S10150, 3501110-S10164, 3501110-S10165, 3501110-S10265, 3501110-S10266, 3501110-S10280, 3501110-S10060, 3501110-S10133, 3501110-S10106, 3511110-S10108, 3511110-S10217, 3511110-S10220, 3501110-S10113, 3501110-S10115, 3501110-S10120, 3501110-S10122, 3501110-S10123, 3501110-S10125, 3501110-S10130, 3501110-S10132, 3511110-S10140, 3511110-S10141, 3511110-S10142, 3511110-S10146, 3501110-S10066, 3501110-S10068, 3501110-S10069, 3501110-S10081, 3501110-S10222, 3501110-S10224, 3501110-S10225, 3501110-S10226, 3501110-S10227, 3501110-S10230, 3501110-S10231, 3501110-S10236, 3501110-S10237, 3501110-S10238, 3501110-S10239, 3501110-S10071, 3501110-S10124, 3501110-S10127, 3511110-S10177, 3511110-S10178, 3511110-S10179, 3511110-S10180, 3511110-S10203
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, HI.IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WI and including Canada.
  • Descripción del producto
    OPERON D850 Surgical Table || Product Usage: Surgical Table
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Berchtold Corp., 1950 Hanahan Rd, N Charleston SC 29406-4878
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA