FDAClass IIAugust 14, 2013

Enterprise 9000 Bed recall

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

Why was Enterprise 9000 Bed recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment…
Recalling firm
Arjo, Inc. dba ArjoHuntleigh
Quantity
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, 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.
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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