Events

Recall of Arjo Maxi 500 Patient Lift with 2Point Spreader Bar and Scale

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
    50098
  • Event Risk Class
    Class 2
  • Event Number
    Z-0412-2009
  • Event Initiated Date
    2008-10-30
  • Event Date Posted
    2008-12-18
  • 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=74718
  • 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
    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.
  • Action
    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 2Point Spreader Bar and Scale
  • Model / Serial
    Model KM560101, serial numbers: KM5611219, KM5611322, KM5611076, KM5610713, KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551, KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006, KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013, KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020, KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027, KM5611084, KM5610813, KM5611290, KM5610667, and KM5611321;  Scale model 700.05505, serial numbers: SO#5140275 and SO#5156094.
  • 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 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with the optional scale kit 700.05505. || The Maxi 500 is a mobile passive lifter, intended to be used for lifting and transferring of patients in hospitals, nursing homes of other health care facilities.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA