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Medical Device Recalls
Class I Recall: Arjo Alenti Lift Hygiene Chair
See Related Information
Date Recall
Initiated
 June 8, 2004
Product:
 Alenti Lift Hygiene Chair
Use:
 The device is a battery operated hygiene lift designed for lifting, moving and bathing of residents. The resident is seated on a polyurethane seat and the chassis has four casters.
Recalling Firm:
 Arjo, Inc.
50 North Gary Avenue
Roselle, IL 60172
Reason for Recall:
 There have been an increased number of incidents of the lifts tipping which have resulted in serious injuries to the patients. Reported causes of the incidents include lift instability on sloped floors, casters falling off of the lift while in use, patients leaning or shifting weight in the seat, and brakes not being applied. Additionally, the device labeling does not properly instruct the health care professional on how to properly secure the patient.
Public Contact:
 Ms. Brenda Ammonette
Quality Assurance Manager
800-323-1245
FDA District:
 Chicago
FDA Comment:
 Users should pay particular attention to the revised Safety Advise Notice and Updated Operating and Product Care Instructions recently provided to all affected customers by the firm. Also a safety belt should be used to secure patients in the lift to provide for greater lift stability. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
 

For additional information on this product recall, see the Arjo Inc. press release at: http://www.fda.gov/cdrh/recalls/recall-060804-pressrelease.html or call Arjo Inc. at 1-800-323-1245, ext. 6140 or 6103.

Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00856.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Updated July 30, 2004

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