| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01442-1 |
| Product Name/Description |
C-Series Lifts
Prism Medical/Waverly Glen FSN-0016A
Item Numbers: 1-323100, 1-323211, 1-323149
Model 323100 C450 Manual Traverse Serial Numbers C4M0018959 and C4M0018962
Model 323211 C450 Manual Traverse Rev A Serial Number C4M0018956
Model 323149 C450 Power Traverse Serial Number C4P0009806
ARTG Number: 169639 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Rehab Assist has been made aware by Prism Medical USA (a division of Handicare), that during an internal cycle testing of C-Series lifts it is determined that the C-Series lift straps for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625lbs). The root cause has been identified as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.
There have been no known incidents of hoists in use, only in internal routine cyclical testing. |
| Recall Action |
Recall |
| Recall Action Instructions |
Rehab Assist will be in contact with affected customers to arrange for replacement of affected devices. This recall action only relates to the serial numbers stated for this Sponsor.
This action has been closed out on 10/09/2018 |
| Contact Information |
03 9729 7978 - Rehab Assist |