| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01233-1 |
| Product Name/Description |
Oxford Dipper Hoist
Models: OP10013, OP10014, X10013 and X10014
Purchased between 2001 and 2010
Multiple Serial Numbers affected
ARTG Number: 101030 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Joerns Healthcare has revised the service life statement and related manufacture guidance for the Oxford Dipper Hoist. It is possible that issues such as corrosion can occur rapidly in units older than 7 years and this may not be externally visible to users. Joerns Healthcare strongly recommends load testing for the Oxford Dipper is carried out at each and every 6 monthly inspection due to the hostile environment in which it resides and operates. The humid and corrosive nature of the pool-side locations can potentially lead to product deficiencies that may otherwise remain undetected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Load testing for the Oxford Dipper should be carried out at every six-monthly inspection
The Oxford Dippers that are older than 7 years need to be changed out prior to the following scheduled (6 monthly) inspection to ensure the ongoing safety of users.
Recipients are requested to contact all customer(s) supplied with the supplied serial numbers, then complete the supplied Receipt Form with the appropriate box checked, according to disposition of each hoist as soon as the information becomes available or the change out is complete.
This action has been closed out on 06/02/2019 |
| Contact Information |
02 9678 6630 - Sunrise Medical |