Recall Z-3070-2011 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc. dba ArjoHuntleigh
Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to
| Date | Aug 24, 2011 (initiated Aug 4, 2011) |
| Status | Terminated |
| Reason | The Entroy Pool Lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver. |
| Root cause | Device Design |
| Action | ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh |
| Quantity | 1 unit in the U.S., 311 units in the rest of the world |
| Distribution | Worldwide Distribution - USA including CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.