Home / Recalls / Arjo, Inc. dba ArjoHuntleigh / Z-0476-2013

Z-0476-2013 Class II Terminated

Recalled by Arjo, Inc. dba ArjoHuntleigh — Addison, IL

FDA device recall Z-0476-2013 was initiated by Arjo, Inc. dba ArjoHuntleigh on November 16, 2012 and is designated Class II. 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 o… The recall status is terminated (terminated September 13, 2016). Affected quantity: 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW.

Recall Details

Product Type: Devices
Report Date: August 14, 2013
Initiation Date: November 16, 2012
Termination Date: September 13, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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

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