| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01330-1 |
| Product Name/Description |
Ceiling mounted rail systems for Liko Overhead Lifts
ARTG Number: 161863 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The issue relates to fasteners securing overhead lift rail systems to ceilings in chlorinated indoor pool applications. Two complaints with no confirmed injuries have been reported to Hill-Rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. Hill-Rom’s analysis has concluded that the root cause is stress corrosion cracking (SCC) on the stainless steel hardware may occur in the presence of chlorinated environments such as swimming pool areas. There is a risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom is advising users that an inspection will be carried out on all potentially affected systems located in a chlorinated environment and if systems are found to be of stainless steel hardware, it will be replaced with unaffected hardware. Hill-Rom is reminding users that periodic inspections are required for the rail systems in accordance with the Instructions for Use (IFU). For more details, please see http://www.tga.gov.au/safety/alerts-device-liko-overhead-lifts-140121.htm . This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 147 118 - Hill-Rom Pty Ltd Technical Support |