Events

Recall of Maxi Move Patient Lift with Lock & Load System (Combi Hanger)

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
    49391
  • Event Risk Class
    Class 2
  • Event Number
    Z-2470-2008
  • Event Initiated Date
    2008-09-08
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73244
  • 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
    There is the potential for unintended dislocation of the lock and load hanger assembly (combi hanger) from the t-bar attached to the lifter jib of the maxi move patient lift.
  • Action
    Arjo sent the Field Safety Notice (FSN) dated 8/11/08 to all Maxi Move with Lock & Load system (Combi Hanger) customers on 9/8/08. The accounts were informed of the problem unintended dislocation of the hanger and possible detachment during patient transfer. The notice provided details, including serial number ranges, to identify the affected patient lifts affected, and instructed the accounts to re-train caregivers on how to ensure the hanger is properly attached to the T-bar before and during the initial phase of all lifting operations. Included with the FSN was a package containing a repair/replacement kit for the bushings in the T-bar with instructions, and updated copies of the Operating and Product Care instructions as well as a Preventative Maintenance Schedule manuals. The accounts were requested to complete and return to Arjo Inc. the enclosed customer response form indicating that they have received the notification package, that they installed the bushings kits in their affected Maxi Moves, or if they would like an Arjo Service Technician to perform the installation. Those locations needing a T-bar replacement will be contacted by an Arjo representative within 2 months to arrange a replacement of the T-bars.

Device

Maxi Move Patient Lift with Lock & Load System (Combi Hanger)
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. || The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.
  • Manufacturer
    Arjo, Inc.

Manufacturer

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