| TGA Action ID |
RC-2026-RN-00305-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Merivaara QFlow lights
Product Name: Q-FLOW DUO
Manufactured before June 2023. |
| ARTG Number |
292143 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In post-market surveillance, Merivaara Corporation has become aware that due to an assembly error, the device’s support
yokes can become loose from their fixings. In the worst case, if these fixing screws become completely loose, the luminaire
may fall off its fixture. This creates a serious risk of injury for the patient and for the user. |
| Instructions for Customers/Users |
Hoyland Medical will:
- Contact customers to organise an inspection or repair of the fixing of the luminaire’s support yoke/yokes by Hoyland Medical's field service engineers.
Customers are to:
- Keep the updated manual maintenance checklist with their installation and maintenance manual.
- Follow the instructions for use and inspect the luminaire daily when cleaning, paying attention to the joints of the support yokes. If looseness is found at these joints during the daily inspection, the luminaire should be taken out of use. |
| Action Commencement Date |
30/04/2026 |
| Responsible Entity |
|
| Contact Information |
07 3390 7011 - Hoyland Medical |