| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00977-1 |
| Product Name/Description |
Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls
Serial numbers: 06JXXXXXXX to 13CXXXXXXX (the first two digits represent the year and the first letter represents the month i.e., A=January, B=February etc)
Affected SPJ+ Joystick models are manufactured between 9 September 2009 to 21 March 2013 and MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) are manufactured between 1 October 2006 to 21 March 2013
ARTG Number: 160385 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. In a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. The unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Invacare is providing distributors with two options to correct the affected joystick. 1) Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare. 2) Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected. For more details, please see http://www.tga.gov.au/safety/alerts-device-invacare-131011.htm This action has been closed-out on 11/04/2016. |
| Contact Information |
1800 460 460 - Invacare Customer Service |