| TGA Action ID |
RC-2026-RN-00454-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hemo Dialysis Machine 4008S V10
Product code: M204001 |
| ARTG Number |
120309 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Sporadic flow alarms have been reported in 4008-HD devices. Investigation identified that the problem originates from minor technical variations in the motor manufacturer’s carbon brushes, which may wear faster than expected. Accelerated wear can lead to premature pump failure, as the rotor becomes insufficiently energised once the carbons are fully worn. This may result in failure of the degassing pump or flow pump, leading to loss of fluid pumping capability. No patient harm has been reported.
This market action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Replacement for the affected motors was delivered in March 2026.
This action has been closed out on 16/07/2026 |
| Action Commencement Date |
23/06/2026 |
| Responsible Entity |
|
| Contact Information |
1800 011 464 - John Peeters, Fresenius Medical Care Australia |