Z-0088-2009

Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision...

Name: Z-0088-2009 Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2008-06-19
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2008-06-19 / Terminated / root cause: software

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision E700 Low Airloss Therapy Surface helps prevent... on 2008-06-19. The reason FDA records is "A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0088-2009
Status: Terminated
Initiated: 2008-06-19
Posted: 2008-10-07
Terminated: 2009-05-21
Recalling firm: Hill-Rom Manufacturing, Inc.
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.
Product code: IOQ Bed, Flotation Therapy, Powered
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Serial numbers DB100527 thru DB101305.

Product code IOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)