Recall Z-0323-2009 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; BHM Medical Inc., Magog, QC, Canada The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities.
| Date | Nov 24, 2008 (initiated Oct 20, 2008) |
| Status | Terminated |
| Reason | The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling. |
| Root cause | Nonconforming Material/Component |
| Action | Arjo sent an Urgent Device Recall Customer Notification letter dated 10/20/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/20/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to shearing of the pivot bolt. The accounts were advised to review the enclosed Safety Advisory Notice, note the affected model and serial numbers, and avoid using the lift under load on a high friction floor like carpet or soft tile while using the hanger bar to move the lift. The accounts were advised that an |
| Quantity | 336 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.