Medical Devices
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Arjo Alenti Lift Hygiene Chair
Class I Recall
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Date Recall
Initiated: |
June 8, 2004 |
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Product:
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Alenti Lift Hygiene Chair |
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Use:
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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. |
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Recalling Firm:
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Arjo, Inc. 50 North Gary Avenue Roselle, IL 60172 |
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Reason for Recall:
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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. |
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Public Contact:
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Ms. Brenda Ammonette Quality Assurance Manager 800-323-1245 |
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FDA District:
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Chicago |
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FDA Comment:
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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 nearby links. |
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