Events

Recall of Arjo Maxi 500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50079
  • Event Risk Class
    Class 2
  • Event Number
    Z-0323-2009
  • Event Initiated Date
    2008-10-20
  • Event Date Posted
    2008-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74676
  • Notes / Alerts
    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.
  • Extra notes in the data
    Non-Ac-Powered Patient Lift - Product Code FSA
  • Reason
    The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.
  • Action
    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
  • Model / 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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA