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.
This recall has been terminated (originally issued August 6, 2013).
- Company
- Arjo, Inc. Dba Arjohuntleigh
- Recall Initiated
- November 16, 2012
- Posted
- August 6, 2013
- Terminated
- September 13, 2016
- Recall Number
- Z-0476-2013
- Quantity
- 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
- Firm Location
- Addison, IL
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
Root Cause
Under Investigation by firm
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.