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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01040-1
Product Name/Description Contoura 1000 and 1080 Beds (used to facilitate management of very obese patients)

All beds manufactured since 2001

ARTG Number: 205734, 206177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/10/2013
Responsible Entity Huntleigh Healthcare Pty Ltd
Reason/Issue There is a low but existing entrapment risk for a patient being treated of this bed while being under a BMI of 40. Small, lightweight patients are at a greater risk of entrapment because their small physical dimensions may enhance their ability to fit into a gap, in whole or in part.
Recall Action Recall for Product Correction
Recall Action Instructions Arjohuntleigh is providing revised Instructions for Use (IFU) and additional labelling on the frame of the affected beds.
Contact Information 1800 072 040 - ArjoHuntleigh Customer Care