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U.S. Department of Health and Human Services

Class 2 Device Recall BHM Kwiktrak Fixed Gate

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  Class 2 Device Recall BHM Kwiktrak Fixed Gate see related information
Date Initiated by Firm October 23, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on January 09, 2010
Recall Number Z-0479-2007
Recall Event ID 36636
Product Classification patient lift component - Product Code FSA
Product BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5.

The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and
b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits
Code Information Part #700.11550 installed in combination with part #700.15515.
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave Ste A
Roselle IL 60172-1684
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall		 The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.
FDA Determined
Cause 2		 Other
Action Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that if the ceiling lift is moved too fast or too forcefully into a closed gate, the gate stopper can be damaged, causing its function to fail. One consequence can be that the gate may remain open, allowing the ceiling lift to pass through to the end of the track. The letters requested the customer to visually inspect their Kwiktrak Gate installation used with their Maxisky-600 Ceiling Lift to determine if there are any signs of impact or burr marks on the closed gate stopper. Illustrations of a damaged and normal gate stopper were included. The customers were requested to stop use of the Kwiktrak track system if any signs of impact or burr marks are found, and contact the Arjo Quality Department at 1-800-323-1245, ext. 6140 for special instructions. If no signs of damage were found, the customers were reminded to make sure that they manually drive the ceiling lift in a gentler manner to prevent damage to the gate stopper, making sure that all personnel using the ceiling lifts are properly trained. The accounts were informed that Arjo personnel will contact them in the next few weeks to install an improved system that will eliminate the risks of failure.
Quantity in Commerce 3 gate systems
Distribution Michigan, Ohio and Illinois
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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