Events

Retiro De Equipo (Recall) de Device Recall Allen Medical

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 The OR Group,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
    26439
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0953-03
  • Fecha de inicio del evento
    2003-06-02
  • Fecha de publicación del evento
    2003-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27685
  • 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
    Operating Room Accessories Table Tray - Product Code FWZ
  • Causa
    Foot stirrups may detach from mount when user is locking system.
  • Acción
    The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement.

Device

Device Recall Allen Medical
  • Modelo / Serial
    Serial Numbers-Domestic (424 units): A024096, A025850, A025851, A025852, A025853, A025854, A025855, A025856, A025857, A025858, A025859, A025946, A025947, A025948, A025949, A025950, A025951, A025952, A025953, A025966, A025967, A025968, A025969, A025970, A025971, A025972, A025973, A025974, A025975, A026140, A026141, A026142, A026143, A026144, A026145, A026146, A026147, A026148, A026149, A026370, A026371, A026372, A026373, A026374, A026375, A026376, A026377, A026378, A026379, A026515, A026516, A026517, A026518, A026519, A026520, A026521, A026522, A026523, A026524, A026624, A026625, A026626, A026627, A026628, A026629, A026630, A026631, A026632, A026633, A026694, A026695, A026777, A026778, A026779, A026780, A026781, A026782, A026783, A026784, A026785, A026786, A026787, A026788, A026789, A026790, A026791, A026792, A026793, A026794, A026795, A026796, A026800, A026801, A026934, A026935, A026936, A026937, A026938, A026939, A026940, A026941, A026942, A026943, A026957, A026958, A026959, A026960, A026961, A026962, A026963, A026964, A027061, A027062, A027063, A027064, A027065, A027066, A027067, A027068, A027069, A027070, A027121, A027122, A027123, A027124, A027125, A027126, A027127,  A027128, A027129, A027130, A027290, A027291, A027292, A027293, A027294, A027295, A027296, A027297, A027298, A027299, A027384, A027385, A027386, A027387, A027388, A027389, A027390, A027391, A027392, A027393, A027562, A027563, A027564, A027565, A027566, A027567, A027568, A027569, A027570, A027571, A027572, A027573, A027574, A027575, A027682, A027683, A027684, A027685, A027937, A027938, A027939, A027940, A027941, A027942, A027943, A027944, A027945, A027946, A028052, A028053, A028054, A028055, A028056, A028057, A028058, A028059, A028060, A028061, A028098, A028099, A028100, A028101, A028102, A028103, A028148, A028149, A028162, A028163, A028164, A028165, A028166, A028167, A028168, A028169, A028170, A028171, A028283, A028284, A028285, A028286, A028287, A028288, A028289, A028290, A028448, A028449, A028450, A028451, A028452, A028453, A028663, A028664, A028681, A028682, A028683, A028684, A028685, A028686, A028687, A028688, A028689, A028690, A028899, A028900, A028957, A028958, A028959, A028960, A028961, A028962, A028963, A028964, A028965, A028966, A028967, A028968, A028969, A028970, A028971, A028972, A028973, A028974, A028975, A028976, A029279, A029280, A029281, A029282, A029283, A029284, A029285, A029286, A029287, A029288, A029289, A029290, A029291, A029292, A029293, A029294, A029295, A029296, A029297, A029298, A029576, A029577, A029578, A029579, A029586, A029587, A029588, A029589, A029590, A029591, A029592, A029593, A029594, A029595, A029659, A029660, A029661, A029662, A029663, A029664, A029665, A029666, A029761, A029762, A029763, A029764, A029765, A029766, A029767, A029768, A029769, A029770, A029863, A029864, A029865, A029866, A029867, A029868, A029869, A029870, A029913, A029914, A029915, A029916, A029917, A029918, A029921, A029922, A029923, A029924, A029925, A029926, A029927, A029928, A030171, A030172, A030173, A030174, A030175, A030176, A030177, A030178, A030179, A030180, A030181, A030182, A030183, A030184, A030185, A030186, A030187, A030188, A030189, A030190, A030191, A030192, A030193, A030194, A030425, A030426, A030427, A030428, A030429, A030430, A030431, A030432, A030522, A030523, A030524, A030525, A030526, A030527, A030528, A030529, A030589, A030590, A030591, A030592, A030593, A030594, A030595, A030596, A030597, A030598, A030599, A030600, A030601, A030602, A030754, A030755, A030756, A030757, A030758, A030759, A030760, A030761, A030762, A030763, A030764, A030765, A030766, A030767, A030768, A030769, A030820, A031009, A031010, A031011, A031012, A031013, A031014, A031015, A031016, A031030, A031031, A031032, A031033, A031034, A031035, A031036, A031037, A031078, A031079, A031080, A031081, A031082, A031083, A031084, A031085. Serial Numbers Foreign (36 units):  206359, 206360, 206361, 206362, 209163, 209164, 209165, 209166, 209328, 209329, 209330, 209331, 210572, 210573, 211166, 211167, 212707, 212708, 213337, 213338, 214426, 214427, 215128, 215129, 215938, 215939, 217715, 217716, 218215, 218216, 218221, 218222, 219680, 219681, 222526, 222527.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,
  • Descripción del producto
    Allen Medical Systems PAL Pro Stirrups || Catalog Number: A-10051-A1
  • Manufacturer
    The OR Group,Inc.

Manufacturer

The OR Group,Inc.
  • Dirección del fabricante
    The OR Group,Inc., A Subsidiary of Hill-Rom Inc., One Post Office Square, Acton MA 01720
  • Source
    USFDA