Recall Z-2470-2008 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residen
| Date | Sep 30, 2008 (initiated Sep 8, 2008) |
| Status | Terminated |
| Reason | There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from the t-bar attached to the lifter jib of the Maxi Move patient lift. |
| Root cause | Device Design |
| Action | Arjo sent the Field Safety Notice (FSN) dated 8/11/08 to all Maxi Move with Lock & Load system (Combi Hanger) customers on 9/8/08. The accounts were informed of the problem unintended dislocation of the hanger and possible detachment during patient transfer. The notice provided details, including serial number ranges, to identify the affected patient lifts affected, and instructed the accounts to re-train caregivers on how to ensure the hanger is properly attached to the T-bar before and during the initial phase of all lifting operations. Included with the FSN was a package containing a repair |
| Quantity | 4,400 patient lifts |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.