Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. 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.
FDA Recall Z-0088-2009 · Posted 2008-10-07
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Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeIOQ
Date Initiated2008-06-19
Date Terminated2009-05-21
Product Quantity779 units
Reason for Recall
A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.
Firm Action
An internal Modification Notice dated 9/1/08 was sent via email to Service Centers (because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the consignee). Each Service Center will perform the correction on the units affected. Each device in the affected serial number range will be tested for the software defect. If the defect is found, the circuit board that contains the defective software will be replaced. The Field Action Plan is expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 months from July, 2008.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution --- including USA and country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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