ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1

FDA device recall Z-0019-2015 · posted 2014-10-06 · Terminated

Recall details

Recalling firm

Arjo Hospital Equipment AB

Reason for recall

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.

Action taken

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 Instructions for Use Manual and new bed label; 3) discard all previous versions of Contoura 1000/1080 Bed Instructions for Use Manuals and ensure that a copy of this Contoura Bed Field Safety Notice is placed in the enclosed revised Contoura 1000/1080 bed Instructions for Use Manual (746-173-AM-3 - 10/2013); 4) where applicable, include this requirement in subsequent training of applicable staff and caregivers; and, 5) complete and sign the enclosed Customer Response Form and return this form to the ArjoHuntleigh Regulatory Department. An ArjoHuntleigh Service Technician will contact the designated facility representative listed on the Customer Response Form to schedule service to apply the two labels shown above, free of charge. For question contact ArjoHuntleigh at 1-800-323-1245, ext. 57985.

Root cause

Labeling design

Status

Terminated

Product code

FNL

Quantity affected

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

Date initiated

2014-03-17

Date posted

2014-10-06

Date terminated

2018-02-14

Location

Eslov, Sweden