| TGA Action ID |
RC-2026-RN-00511-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BESDATA Single Use Scope Console / Image Processor
Product Code: MIP-1002
Serial Number: 251018011 |
| ARTG Number |
478085 |
| Unique Device Identifier (UDI) |
(01)06971355352356(11)251018(17)301017(21)251018010 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The device label on the affected unit shows an incorrect model name and serial number.
The EndoScope WorkStation MIP-1003 SN# 251018010 was incorrectly labelled as MIP-1002 SN# 251018011.
The device’s casing did not feature a screw limiting function, appropriate labelling and warning statements regarding the internal lithium-ion battery.
A penetrated lithium battery may result in smoke, ignition or explosion.
This action does not affect any other Besdata products.
This action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Customers are to:
- Complete the Customer Response form to confirm that the affected product has been discarded.
This action has been closed out on 03/08/2026 |
| Action Commencement Date |
9/07/2026 |
| Responsible Entity |
|
| Contact Information |
CIME@OPAQE.AU - Michael Mortimer, CIME Director |