Print version of this report
TGA Action ID
RC-2026-RN-00105-1
Type of Product
Medical Device
Product Name/Description
CelonProBreath
Model Numbers: WB990004, WB990007
Lot Numbers: 1000170763, 1000170774, 1000170800, 1000170804, 1000170805, 1000170806, 1000169475, 1000171773, 1000172947, 1000172948
1000172949
ARTG Number
214947
Action Type
Product Correction
Action Level
Hospital
Hazard Classification
Class III
Reason for the Action
Olympus has identified that certain boxes of CelonProBreath bipolar applicator was released to customers without the required Instructions for Use (IFU) included. Olympus' investigation concluded that the cause of the problem was a software configuration error in the packaging process which allowed these devices to be packaged without the IFU. The software configuration error has since been resolved.
No complaints or adverse events have been reported to Olympus regarding the missing IFU.
Instructions for Customers/Users
Customers are to check inventory for impacted lots and ensure a copy of the IFU (supplied with the Customer Letter) is placed with the device.
This action has been closed out on 09/06/2026
Action Commencement Date
10/02/2026
Responsible Entity
Olympus Australia Pty Ltd
Contact Information
1300 132 992 - Olympus Customer Operations