Z-2434-2008

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

Name: Z-2434-2008 Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate...
Creator: Arjo, Inc.
Published: 2008-08-01
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2008-08-01 / Terminated / root cause: design

FDA source

Arjo, Inc. began a recall of 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... on 2008-08-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2434-2008
Status: Terminated
Initiated: 2008-08-01
Posted: 2008-09-20
Terminated: 2010-01-05
Recalling firm: Arjo, Inc.
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: part 700.11560, serial numbers GA-1304-0001 to GA-2608-1374, and part 700.11550, all units

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)