Recall Z-0476-2013 · FNL Bed, Ac-Powered Adjustable Hospital

Arjo, Inc. dba ArjoHuntleigh

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

Date	Aug 6, 2013 (initiated Nov 16, 2012)
Status	Terminated
Reason	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.
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
Quantity	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, Fr
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.