Recall Z-0479-2007 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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 Gat
| Date | Jan 11, 2007 (initiated Oct 23, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 3 gate systems |
| Distribution | Michigan, Ohio and Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.