| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01185-1 |
| Product Name/Description |
Corpus Powered Wheelchairs
(with fixed seat and elevator inner tubes)
Model: C300 Corpus II
Serial Numbers: 2537002437, 2537002471, 2537002476, 2537002514, 2537002746, 2537002891 and 2537002956
Model: C350 Corpus II
Serial Number: 43203511
Model: C500 Corpus II
Serial Number: 15702655
Model: C500 Corpus II LR
Serial Numbers: 2557000160 and 2557000185
ARTG Number: 224603 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. The top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. The consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. Out of 71 cases reported to the US FDA, 3 serious injuries occurred (2 broken bones and 1 laceration). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction.
For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-system
This action has been closed out on 30/10/2018 |
| Contact Information |
1300 845 483 - Permobil Australia |