Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy

FDA device recall Z-3070-2011 · posted 2011-08-24 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

Reason for recall

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.

Action taken

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 at 1-800-323-1245, ext 54485.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

1 unit in the U.S., 311 units in the rest of the world

Distribution

Worldwide Distribution - USA including CT

Date initiated

2011-08-04

Date posted

2011-08-24

Date terminated

2011-11-28

Location

Addison, IL