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

FDA device recall Z-0088-2009 · posted 2008-10-07 · Terminated

Recall details

Recalling firm

Hill-Rom Manufacturing, Inc.

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.

Action taken

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

Status

Terminated

Product code

IOQ

Quantity affected

779 units

Distribution

Worldwide Distribution --- including USA and country of Canada.

Date initiated

2008-06-19

Date posted

2008-10-07

Date terminated

2009-05-21

Location

Charleston, SC