Recall Z-1650-2008 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model AB1102 - Standard basic model Ambulift with chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and leg rest and scales.
| Date | Aug 28, 2008 (initiated May 5, 2008) |
| Status | Terminated |
| Reason | The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries. |
| Root cause | Device Design |
| Action | Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient men |
| Quantity | 11 lifts |
| Distribution | Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.