Events

Recall of Maxi Move Scoop Stretcher

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

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
    52824
  • Event Risk Class
    Class 2
  • Event Number
    Z-2230-2009
  • Event Initiated Date
    2009-08-18
  • Event Date Posted
    2009-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84080
  • 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
    A scoop stretcher is made up of two frames that are held together with two locking devices, one on each end. each locking device contains a safety latch. the safety latch could unintentionally release when the side frames are pulled for positioning.
  • Action
    ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher: * Place the stretcher on its side on a non-scratch surface. * Try to pull the two sides apart with the safety latch engaged. * Test both the head and foot ends of the stretcher. * If the stretcher pulls apart, remove it from use immediately. It is important to note that all affected stretchers will be upgraded, whether they fail the test or not.

Device

Maxi Move Scoop Stretcher
  • Model / Serial
    all six digit serial numbers beginning with 6xxxxx and all serial numbers 08xxxxxxxx up to 0812001186.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh
  • Manufacturer Address
    ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA