| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00160-1 |
| Product Name/Description |
Zippie Zone Wheelchair
Model Number: EIRZ1
ARTG Number: 100167
(SUNRISE MEDICAL PTY LIMITED - Wheelchair, ) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
The Zippie Zone Instructions For Use (IFU) have been updated to provide clarification on the intended use and the correct prescription of the wheelchair prior to purchase. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The IFU updates cover the correct usage of the chair and also improved guidance in the correct product selection and client suitability information.
Customers with this particular chair model may download the updated instructions at:
http://www.sunrisedice.com/asset-bank/assetfile/25518.pdf
If users have any concerns regarding the correct usage/application or prescription regarding the chair they have been supplied, it is advised to discuss these concerns with the therapist or supplier in the first instance.
Sunrise Medical is also providing a new "Paediatric Prescription Guide" to clients, therapists and clinicians as a reference whilst prescribing and/or assessing clients.
This action has been closed out on 13/02/2019 |
| Contact Information |
02 9678 6600 - Sunrise Medical |