| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00288-1 |
| Product Name/Description |
Surdial X
Serial number: 22DS10671
ARTG 211174
(Nipro Australia Pty Ltd - Haemodialysis system, institutional) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Nipro Australia has supplied dialysis machines Surdial X with European type C power plugs. An electrical fault on Surdial X machine was reported in which the device alarmed and the plug was blackened.
Nipro are replacing all incorrect plugs with the Australian type I plug that meets the Australian standards.
This recall action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Nipro advise that they will replace the European type C plug with an Australian type I plug purchased in the Australia market that has met Australian standard, and electrical safety tests have also been conducted as part of the installation process.
This action has been closed out on 08/05/2024 |
| Contact Information |
0417 565 830 - Alex McMichael |