Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm,

FDA device recall Z-0477-2013 · posted 2013-08-06 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

Reason for recall

ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.

Action taken

Please be aware that this is not a new recall. Posting to the Internet was delayed due to a technical error. ArjoHuntleigh sent an Urgent Field Correction Recall letters dated November 16, 2012, to all affected customers, informing the accounts of reports of unintended movement of the backrest and/or thigh sections of the bed without intentional activation of the control buttons, which could have serious consequences due to the patient's links to other life supporting devices. The accounts were requested to disseminate the information to all users of the affected beds, to attach the enclosed warning labels to the outside of both head end safety sides immediately adjacent to the controls, to include a copy of the notice in the Instruction for Use Manuals for their beds, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FNL

Quantity affected

1,324 beds in USA, 138 beds in Canada, 1,877 beds ROW

Distribution

Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China

Date initiated

2012-11-16

Date posted

2013-08-06

Date terminated

2016-09-13

Location

Addison, IL