| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00762-1 |
| Product Name/Description |
Contoura 380 and 480 Bed
Manufactured between 12 January 2011 to 31 December 2011
ARTG Number: 205117 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
During investigations by ArjoHuntleigh it has been determined that the DIN connector used on these beds has been compromised during the cable manufacturing process. The supplier has determined that liquid droplets have been found inside the male DIN connector. This substance has been identified as phosphorous that is leaching from the black plastic flame reduction material used in the DIN connector. The effects of this can lead to a high resistance (ohm) connection between the pins and could result in the beds performing uncommanded movements. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are requested to remove beds from use and contact the ArjoHuntleigh Service Line immediately if at any time a Contoura 380 or 480 bed performs uncommanded movement. An ArjoHuntleigh Technician will attend each facility to replace any defective DIN connectors. DIN Connectors with production batch date of October or November 2010 will need to be replaced. DIN Connectors with production batch date of January 2011 and February 2011 will undergo a Megger test which will determine if the connector needs to be replaced. This action has been closed-out on 19/05/2016. |
| Contact Information |
08 9314 4117 - ArjoHuntleigh Quality and Regulatory Officer |