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U.S. Department of Health and Human Services

Class 2 Device Recall Envision E700 Low Airloss Therapy Surface

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  Class 2 Device Recall Envision E700 Low Airloss Therapy Surface see related information
Date Initiated by Firm June 19, 2008
Date Posted October 07, 2008
Recall Status1 Terminated 3 on May 21, 2009
Recall Number Z-0088-2009
Recall Event ID 49490
Product Classification Powered Flotation Therapy Bed - Product Code IOQ
Product 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.
Code Information Serial numbers DB100527 thru DB101305.
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Joe Fogel
843-740-8586
Manufacturer 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.
FDA Determined
Cause 2		 Software change control
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.
Quantity in Commerce 779 units
Distribution Worldwide Distribution --- including USA and country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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