| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00602-1 |
| Product Name/Description |
500 Series Vertical Rails
Part Number: R21-P
ARTG Number:179151 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The bed rails do not comply with recent changes to IEC 60601-2-38:1996 with regard to potential patient entrapment and side rail latches/ locks requirements. |
| Recall Action |
Recall |
| Recall Action Instructions |
Better Living care is requesting their customers and end users to quarantine all affected units. Better Living Care will arrange for the recovery and replacement of the devices. |
| Contact Information |
02 8853 1100 - Better Living Care Pty Ltd |