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U.S. Department of Health and Human Services

Class 2 Device Recall BHM Kwiktrak Gate System

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 Class 2 Recall
BHM Kwiktrak Gate System
see related information
Date Posted September 20, 2008
Recall Status1 Terminated on January 05, 2010
Recall Number Z-2434-2008
Recall Event ID 49102
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product 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.
Code Information part 700.11560, serial numbers GA-1304-0001 to GA-2608-1374, and part 700.11550, all units
Recalling Firm/
Manufacturer
Arjo, Inc.
50 Gary Ave Ste A
Roselle, Illinois 60172-1684
For Additional Information Contact Ms. Traci Giovenco
800-323-1245 Ext. 6125
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 230 units
Distribution Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, New York, North Carolina, Ohio, Oklahoma, Texas, and Wisconsin.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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