| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01216-1 |
| Product Name/Description |
KM8020 III Karma Eagle Wheelchair
Models: KM8020Q-14/ KM8020Q-16/ KM8020Q-1618/ KM8020Q-18/ KM8020Q-1818
Multiple serial numbers
ARTG 182294
(Independent Healthcare Solutions - Wheelchair, attendant/occupant driven) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2022 |
| Responsible Entity |
|
| Reason/Issue |
The user manual delivered with this product was incorrect. On page 31 the specification table incorrectly states that the Maximum user weight is 160kg. The correct user weight is 130kg.
Users may be misinformed about the safe user weight of the wheelchair. Risks associated with this issue include wheelchair breakage, collapse, user fallout and injury.
The sticker on the chair itself correctly identifies the maximum user weight. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Independent Healthcare Solutions are advising customers to discard the old user manual and replace it with the new instruction manual (provided by the sponsor).
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 783 783 - Independent Healthcare Solutions |