Company: Hill-Rom Manufacturing, Inc
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Envision E700 Low Airloss Therapy Surface. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4’11” and 6′ 4″ in height, Recall # Z-0088-2009
REASON
A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by Modification Notice dated September 1, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
779 units
DISTRIBUTION
Nationwide and Internationally
