Recall Z-0019-2015 ยท FNL Bed, Ac-Powered Adjustable Hospital
Arjo Hospital Equipment AB
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended
| Date | Oct 6, 2014 (initiated Mar 17, 2014) |
| Status | Terminated |
| Reason | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. |
| Root cause | Labeling design |
| Action | ArjoHuntleigh sent an URGENT FIELD SAFETY NOTICE - IMMEDIATE ATTENTION REQUIRED letters dated March 17, 2014 to all affected cusomers. The letters included instructions for customers to: 1) ensure that the Contoura Bed Field Safety Notice brought to the attention of all caregivers and clinical staff and they are aware that the Contoura 1000 or 1080 medical bed is intended to be used as a bariatric medical bed, designed for the patients with BMI greater than 40; 2) ensure that all users of the Contoura 1000/1080 bed, applicable staff and caregivers are trained to ensure awareness of the revised |
| Quantity | 1,695 beds (worldwide) |
| Distribution | Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Neth |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.