| TGA Action ID |
RC-2025-RN-00503-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
corpuls3 and corpuls3 Touch
Product Codes: CP-4100, CP-04101
Software Version: REL 4.3.2 |
| ARTG Number |
192745 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer has received reports in which the Display Module of the corpuls3 system has unexpectedly shut down and initiated an automatic reboot during patient care. This results in a temporary interruption of certain device functions, typically lasting between 15 to 45 seconds, with an average duration of 23 seconds.
This limited reboot is triggered by the device’s internal software safety mechanisms as part of its fault management strategy. The function is designed to preserve core functionality and maintain operational safety. Importantly, this does not represent a full system reboot; once the Display Module restarts, the device continues to operate as intended without the need for user intervention.
At present, there have been no reports of patient harm associated with this behaviour.
This action follows on from the previously communicated Urgent Product Alert with TGA reference RC-2024-RN-01161-1, dated 23rd December 2024. |
| Instructions for Customers/Users |
Software version, REL 4.4.2, will be released to fix this problem.
Device Technologies will contact customers to coordinate the update of affected devices.
This action has been superseded by RC-2026-RN-00259-1.
This action has been closed out on 01/07/2026. |
| Action Commencement Date |
31/10/2025 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |