Z-0476-2013Class II

Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000...

Name: Z-0476-2013 Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000...
Creator: Arjo, Inc. dba ArjoHuntleigh
Published: 2012-11-16
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2012-11-16 / Terminated

FDA source

Arjo, Inc. dba ArjoHuntleigh began a recall of Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General... on 2012-11-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0476-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-16
Posted: 2013-08-06
Terminated: 2016-09-13
Recalling firm: Arjo, Inc.
Product: Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 94 beds in U.S., 31 beds in Canada, 26,010 beds in 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, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen.
Product codes and lots: Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0476-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0476-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-0477-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06

Product code FNL

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)