| 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 |
|
| 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 |