Events

Retiro De Equipo (Recall) de Arjo Maxi 500

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 Arjo, 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
    50079
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0323-2009
  • Fecha de inicio del evento
    2008-10-20
  • Fecha de publicación del evento
    2008-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74676
  • 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
    Non-Ac-Powered Patient Lift - Product Code FSA
  • Causa
    The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.
  • Acción
    Arjo sent an Urgent Device Recall Customer Notification letter dated 10/20/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/20/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to shearing of the pivot bolt. The accounts were advised to review the enclosed Safety Advisory Notice, note the affected model and serial numbers, and avoid using the lift under load on a high friction floor like carpet or soft tile while using the hanger bar to move the lift. The accounts were advised that an Arjo Field Service Technician would contact them within two weeks to schedule a visit to the account to perform repairs on their Maxi 500 lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Urgent Device Correction.

Device

Arjo Maxi 500
  • Modelo / Serial
    serial numbers KM5610785, KM5610162, KM56510020, KM5610290, KM5610251, KM5610309, KM5610428, KM5610247, KM5610165, KM5610278, KM5610282, KM5610752, KM5610824, KM5610826, KM5610852, KM5610410, KM5610420, KM5610302, KM5610294, KM5610045, KM5610701, KM5610407, KM5610916, KM5610985, KM5610881, KM5610239, KM5610243, KM5610249, KM5610177, KM5610726, KM5610272, KM5610297, KM5610187, KM5610333, KM5610051, KM5610164, KM5610057, KM5610736, KM5610100, KM5610101, KM5610104, KM5610329, KM5610429, KM5610241, KM5610735, KM5610285, KM5610750, KM5610056, KM5610806, KM5610118, KM5610702, KM5610152, KM5610153, KM5610784, KM5610788, KM5610808, KM5610047, KM5610304, KM5610892, KM5610158, KM5610434, KM5610437, KM5610105, KM5610335, KM5610815, KM5610276, KM5610326, KM5610037, KM5610166, KM5610126, KM5610982, KM5610246, KM5610046, KM5610280, KM5610756, KM5610167, KM5610858, KM5610337, KM5610341, KM5610890, KM5610913, KM5610915, KM5610755, KM5610988, KM5610041, KM5610424, KM5610427, KM5611002, KM5610043, KM5610132, KM5610418, KM5610323, KM5610704, KM5610050, KM5610096, KM5610098, KM5610179, KM5610438, KM5610831, KM5610155, KM5610035, KM5610331, KM5610097, KM5610296, KM5610236, KM5610240, KM5610242, KM5610305, KM5610237, KM5610954, KM5611001, KM5610841, KM5610843, KM5610855, KM5610235, KM5610827, KM5610830, KM5610840, KM5610833, KM5610832, KM5610264, KM56510017, KM5610440, KM56510023, KM5610992, KM5610110, KM5610298, KM5610342, KM5610814, KM5610816, KM5610818, KM5610891, KM5610888, KM5610117, KM5610121, KM5610125, KM5610127, KM5610163, KM5610168, KM5610169, KM5610176, KM5610406, KM5610426, KM5610999, KM5610292, KM5610293, KM5610310, KM5610336, KM5610317, KM5610123, KM5610430, KM5610441, KM5610432, KM56510019, KM5610054, KM5610107, KM5610173, KM5610413, KM56510018, KM5610036, KM5610055, KM5610271, KM5610238, KM5610722, KM5610724, KM5610758, KM5610981, KM5610338, KM5610129, KM5610300, KM5610226, KM5610059, KM5610723, KM5610263, KM5610260, KM5610113, KM5610340, KM5610303, KM5610306, KM5610315, KM5610339, KM5610160, KM5610161, KM5610128, KM5610049, KM5610857, KM5610596, KM5610343, KM56510015, KM5610879, KM5610914, KM5610978, KM5610109, KM5610262, KM5610265, KM5610439, KM5610725, KM5610314, KM5610320, KM5610244, KM5610245, KM5610042, KM5610786, KM5610301, KM5610753, KM5610757, KM5610805, KM5610281, KM5610703, KM5610058, KM5610415, KM5610321, KM5610120,  KM5610124, KM5610131, KM5610157, KM5610181, KM5610286, KM5610178, KM5610850, KM5610116, KM5610284, KM5610409, KM5610106, KM5610112, KM56510021, KM56510022, KM56510024, KM5610983, KM5610182, KM5610828, KM5610998, KM5610122, KM5610849, KM5610853, KM5610334, KM5610989, KM5610064, KM5610052, KM5610312, KM5610044, KM5610170, KM5610953, KM5610787, KM5610250, KM5610436, KM5610066, KM5610102, KM5610856, KM5610408, KM5610878, KM5610274, KM5610061, KM5610103, KM5610332, KM5610119, KM5610130, KM5610275, KM5610416, KM5610419, KM5610133, KM5610980, KM5610065, KM5610154, KM5610159, KM5610414, KM5610990, KM5610269, KM5610288, KM5610421, KM5610433, KM5610327, KM5610322, KM5610268, KM5610700, KM5610048, KM56510016, KM5610253, KM5610257, KM5610889, KM5610099, KM5610108, KM5610422, KM5610880, KM5610751, KM5610984, KM5610987, KM5610156, KM5610270, KM5610038, KM5610749, KM5610754, KM5610411, KM5610316, KM5610319, KM5610324, KM5610817, KM5610053, KM5610295, KM5610254, KM5610062, KM5610039, KM5610325, KM5610180, KM5610171, KM5610435, KM5610311, KM5610423, KM5610991, KM5610950, KM5610951, KM5610952, KM5610425, KM5610417, KM5610328, KM5610063, KM5610412, KM5610111, KM5610267, KM5610060, KM5610308, KM5610825, KM5610261, KM5610839, KM5610842, KM5610854, KM5610431, KM5610748, KM5610307, KM5610313, KM5610289, KM5610291, KM5610299, KM5610851, KM5610318, and KM5610330.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; BHM Medical Inc., Magog, QC, Canada || The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Dirección del fabricante
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA