CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report

Enterprise 8000 Bed recalled by Arjo

Arjo is recalling Enterprise 8000 Bed, distributed nationwide in the US. The recall was initiated on 16 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModels 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers

Quantity recalled94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0476-2013
FDA event ID: 63187
Recalling firm: Arjo, Addison, IL
Classification: Class II
Status: Terminated
Recall initiated: 16 Nov 2012
FDA classified: 6 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Wheelchairs, Beds & Lifts

Timeline

16 Nov 2012	Recall initiated by company
6 Aug 2013	Classified by FDA	+263 days
14 Aug 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Enterprise 8000 Bed recalled?

Yes. Arjo recalled Enterprise 8000 Bed on 16 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0476-2013.

Why was it recalled?

Which lots are affected?

Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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