| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00669-3 |
| Product Name/Description |
Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)
Supplied prior to December 2010
Model Number: KW01
ARTG Number: 175458 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
The TGA received an incident report and examined a Kidwalk mobility aid, which had failed at the base of the mast. TGA’s investigation recommended to reinforce and update three important points in the Owner’s Manual (Instructions For Use) for the Kidwalk with aluminium mast supplied prior to December 2010:
· Considerations on re-issue of the KidWalk.
· Regular inspection and annual service of the KidWalk
· The intended purpose of the KidWalk.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update to the Instructions for Use (IFU). |
| Contact Information |
02 8818 2817 - Otto Bock Australia |