Events

Retiro De Equipo (Recall) de Arjo Maxi 500 Patient Lift with Manual 4Point DPS and Scale

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
    50098
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0413-2009
  • Fecha de inicio del evento
    2008-10-30
  • Fecha de publicación del evento
    2008-12-18
  • 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=74719
  • 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
    If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
  • Acción
    Arjo, Inc. sent an Urgent Device Recall Customer Notification letter dated 10/29/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/30/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale if the spring pin is not replaced into the pivot bolt after performing maintenance on the lift. The accounts were advised to review the enclosed Urgent Field Safety Notice, note the affected model and serial numbers, and inspect their lifts for the presence of the spring pin in the pivot bolt. If the user finds that the spring pin is missing, they are instructed to immediately stop using the lift and contact their Arjo representative. The accounts were also instructed to remove previous versions of the Operating and Product Care instructions, and replace them with the current version 001.20815.EN Rev3 dated October 2008 provided with the letter, ensuring that the proper personnel are made aware of the changes outlined in the Field Safety Notice. Direct questions to the Arjo, Inc. Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax (888-594-2756) to Arjo, Inc. 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 Field Safety Notice.

Device

Arjo Maxi 500 Patient Lift with Manual 4Point DPS and Scale
  • Modelo / Serial
    Model KM560181, serial numbers: KM5610035, KM5610036, KM5610037, KM5610038, KM5610039, KM5610040, KM5610041, KM5610042, KM5610043, KM5610044, KM5610045, KM5610046, KM5610047, KM5610048, KM5610049, KM5610050, KM5610051, KM5610052, KM5610053, KM5610054, KM5610055, KM5610056, KM5610057, KM5610058, KM5610059, KM5610060, KM5610061, KM5610062, KM5610063, KM5610064, KM5610065, KM5610066, KM5610096, KM5610097, KM5610098, KM5610099, KM5610100, KM5610101, KM5610102, KM5610103, KM5610104, KM5610105, KM5610106, KM5610107, KM5610108, KM5610109, KM5610110, KM5610111, KM5610112, KM5610113, KM5610116, KM5610117, KM5610118, KM5610119, KM5610120, KM5610121, KM5610122, KM5610123, KM5610124, KM5610125, KM5610126, KM5610127, KM5610128, KM5610129, KM5610130, KM5610131, KM5610132, KM5610133, KM5610152, KM5610153, KM5610154, KM5610155, KM5610156, KM5610157, KM5610158, KM5610159, KM5610160, KM5610161, KM5610162, KM5610163, KM5610164, KM5610165, KM5610166, KM5610167, KM5610168, KM5610169, KM5610170, KM5610171, KM5610173, KM5610176, KM5610177, KM5610178, KM5610179, KM5610180, KM5610181, KM5610182, KM5610187, KM5610235, KM5610236, KM5610237, KM5610238, KM5610239, KM5610240, KM5610241, KM5610242, KM5610243, KM5610244, KM5610245, KM5610246, KM5610247, KM5610249, KM5610250, KM5610251, KM5610253, KM5610254, KM5610257, KM5610260, KM5610261, KM5610262, KM5610263, KM5610264, KM5610265, KM5610266, KM5610267, KM5610268, KM5610269, KM5610270, KM5610271, KM5610272, KM5610273, KM5610274, KM5610275, KM5610276, KM5610278, KM5610280, KM5610281, KM5610282, KM5610284, KM5610285, KM5610286, KM5610288, KM5610289, KM5610290, KM5610291, KM5610292, KM5610293, KM5610294, KM5610295, KM5610296, KM5610297, KM5610298, KM5610299, KM5610300, KM5610301, KM5610302, KM5610303, KM5610304, KM5610305, KM5610306, KM5610307, KM5610308, KM5610309, KM5610310, KM5610311, KM5610312, KM5610313, KM5610314, KM5610315, KM5610316, KM5610317, KM5610318, KM5610319, KM5610320, KM5610321, KM5610322, KM5610323, KM5610324, KM5610325, KM5610326, KM5610327, KM5610328, KM5610329, KM5610330, KM5610331, KM5610332, KM5610333, KM5610334, KM5610335, KM5610336, KM5610337, KM5610338, KM5610339, KM5610340, KM5610341, KM5610342, KM5610343, KM5610406, KM5610407, KM5610408, KM5610409, KM5610410, KM5610411, KM5610412, KM5610413, KM5610414, KM5610415, KM5610416, KM5610417, KM5610418, KM5610419, KM5610420, KM5610421, KM5610422, KM5610423, KM5610424, KM5610425, KM5610426, KM5610427, KM5610428, KM5610429, KM5610430, KM5610431, KM5610432, KM5610433, KM5610434, KM5610435, KM5610436, KM5610437, KM5610438, KM5610439, KM5610440, KM5610441, KM5610596, KM5610700, KM5610701, KM5610702, KM5610703, KM5610704, KM5610722, KM5610723, KM5610724, KM5610725, KM5610726, KM5610735, KM5610736, KM5610748, KM5610749, KM5610750, KM5610751, KM5610752, KM5610753, KM5610754, KM5610755, KM5610756, KM5610757, KM5610758, KM5610784, KM5610785, KM5610786, KM5610787, KM5610788, KM5610805, KM5610806, KM5610808, KM5610814, KM5610815, KM5610816, KM5610817, KM5610818, KM5610824, KM5610825, KM5610826, KM5610827, KM5610828, KM5610830, KM5610831, KM5610832, KM5610833, KM5610839, KM5610840, KM5610841, KM5610842, KM5610843, KM5610849, KM5610850, KM5610851, KM5610852, KM5610853, KM5610854, KM5610855, KM5610856, KM5610857, KM5610858, KM5610878, KM5610879, KM5610880, KM5610881, KM5610888, KM5610889, KM5610890, KM5610891, KM5610892, KM5610913, KM5610914, KM5610915, KM5610916, KM5610950, KM5610951, KM5610952, KM5610953, KM5610954, KM5610978, KM5610980, KM5610981, KM5610982, KM5610983, KM5610984, KM5610985, KM5610986, KM5610987, KM5610988, KM5610989, KM5610990, KM5610991, KM5610992, KM5610998, KM5610999, KM5611001, KM5611002, KM5611093, KM5611096, KM5611097, KM5611098, KM5611099, KM5611101, KM5611121, KM5611123, KM5611124, KM5611125, KM5611137, KM5611138, KM5611139, KM5611187, KM5611188, KM5611190, KM5611233, KM5611235, KM5611237, KM5611293, KM5611294, KM5611295, KM5611296, KM5611307, KM5611324, KM5611327, KM5611329, KM5611330, KM5611331, KM5611395, KM5611396, KM5611402, KM56510015, KM56510016, KM56510017, KM56510018, KM56510019, KM56510020, KM56510021, KM56510022, KM56510023 and KM56510024; Scale model 700.19251, serial numbers: SO#5178400, SO#5143612, SO#5204405, SO#5186264, SO#5137047, SO#5150226, SO#5156912, SO#5162379, SO#5165403 and SO#5142409.
  • 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 Manual 4-Point DPS (Dynamic Positioning System) and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560181 and Model KM560081 - Maxi 500 with 4-Point Spreader Bar, if it was equipped with the optional scale kit 700.19251.
  • Manufacturer
    Arjo, Inc.

Manufacturer

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