Events

Recall of BHM Kwiktrak Gate System

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
    49102
  • Event Risk Class
    Class 2
  • Event Number
    Z-2434-2008
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72770
  • 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 a possibility that the kwiktrak gate system could malfunction, resulting in the gate locks opening even though the corresponding tracks are not properly aligned.
  • Action
    Arjo Inc. USA sent Urgent Field Safety Notice letters dated 8/1/08 to the direct accounts on 8/1/08, informing them that there is a remote possibility that the gate system could malfunction. The result of this malfunction is that the gate locks could open even though the corresponding tracks are not properly aligned. This could result in the lift/cassette falling off the track system, possibly resulting in serious personal injuries and or property damage. The letters requested the customer to immediately implement special operating instructions in their facility to ensure great care is used when the gate system is operated. All personnel must be made aware that the tracks need to be properly aligned before using the gate. Illustrations of an unaligned gate system with an open lock and properly aligned tracks and gate system with open locks were included. Any questions the customers may have were directed to the Arjo Quality Department at 1-800-323-1245, ext. 6125. The accounts were informed that Arjo personnel will contact them in September 2008 to install a permanent add-on improvement to prevent the occurrence of a malfunction. The accounts were requested complete the enclosed response form indicating that they have read and understood the 8/1/08 letter, and fax it back to Arjo at 888-594-2756.

Device

BHM Kwiktrak Gate System
  • Model / Serial
    part 700.11560, serial numbers GA-1304-0001 to GA-2608-1374, and part 700.11550, all units
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, New York, North Carolina, Ohio, Oklahoma, Texas, and Wisconsin.
  • Product Description
    Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; || The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) || Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. || The equipment is intended for transferring lifts from one system track to another.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA