| TGA Action ID |
RC-2025-RN-00644-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
RC- Digital Radiography System RADspeed Pro CH-200 Type B
Serial Numbers: MQ92800E8004, MQ92800E8005, MQ92800E8006, MQ92800E9005, MQ92800E9006
Product Codes: 566/26100/55 |
| ARTG Number |
141009 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
It was found out that the infrared remote-control holder for the CH-200 did not have an emergency “Stop Label” on it.
Therefore, the product does not comply with the requirements of the harmonized standards. However, there are no problems with the functionality of the emergency stop switch or remote and it remains identifiable. |
| Instructions for Customers/Users |
The emergency stop switch remains functional and identifiable and should continue to be used.
Shimadzu will affix a “STOP” label next to the switch in the coming weeks.
This action has been finalised on 28/10/2025. |
| Action Commencement Date |
23/07/2025 |
| Responsible Entity |
|
| Contact Information |
0298982444 - Bill Hepburn |