Recall Z-2434-2008 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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) Manufact
| Date | Sep 20, 2008 (initiated Aug 1, 2008) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.