Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists

FDA device recall Z-2434-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Arjo, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

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.

Date initiated

2008-08-01

Date posted

2008-09-20

Date terminated

2010-01-05

Location

Roselle, IL