| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00892-1 |
| Product Name/Description |
Quickie Q7 Manual Wheelchair
Model Number: EIR4
Serial Number Range: R4-007239 to R4-022394
Manufactured between 1 September 2009 and 27 November 2013
ARTG Number: 100167 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that over time, and under some usage conditions, the backrest brackets may break and detach from the chair frame. If a backrest bracket breaks and goes unnoticed by the user or care giver, there is a risk that the occupant could fall out of the seat and sustain injury to the head or lower back. The expected failure rate of the issue is 1.75%. There have been four reported injuries as a result of users unexpectedly falling from the seats. If a backrest bracket breaks and goes unnoticed by the user or caregiver, there is a risk for the occupant to fall out of the seat and sustain an injury to the head or lower back. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Consumers will be contacted by the dealer who supplied the device to arrange replacement of affected backrest brackets. Sunrise Medical is providing dealers with a replacement bracket kit to be installed on all affected wheelchairs. Wheelchairs manufactured after 27 November 2013 are unaffected by this issue. For more details, please see https://www.tga.gov.au/alert/quickie-q7-manual-wheelchair .
This action was closed out on the 24/09/2018. |
| Contact Information |
02 9678 6630 - Sunrise Medical |