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

Z-0476-2013 Class II Terminated

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

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

Other recalls by Arjo, Inc. dba ArjoHuntleigh

  • Z-2714-2017 Class II — ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to (June 14, 2017)
  • Z-1388-2016 Class II — The Concerto Basic Shower Trolley is intended for assisted hygiene care, especia (December 21, 2015)
  • Z-0079-2015 Class II — Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and la (January 21, 2013)
  • Z-0615-2013 Class II — Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein throm (December 10, 2012)
  • Z-0477-2013 Class II — Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electro (November 16, 2012)
  • Z-1948-2012 Class II — Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, G (June 29, 2012)
  • Z-1949-2012 Class II — Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Product (June 29, 2012)
  • Z-1947-2012 Class II — Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, G (June 29, 2012)