| TGA Action ID |
RC-2026-RN-00050-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
C-MAC 8403 range of Video Laryngoscopes
Material Numbers: 8403AX, 8403AXC, 8403BX, 8403BXC, 8403DXC, 8403EXC, 8403GXC, 8403HX, 8403HXK, 8403HXP, 8403KXC, 8403MXC
Multiple Product Descriptions
All Serial Numbers |
| ARTG Number |
285413 |
| Unique Device Identifier (UDI) |
4048551001493U8 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In some cases, the cover glass of the camera and/or the LED on the 8403 Series Video Laryngoscopes can come away from the device. The user is instructed to inspect the device for such faults prior to use as specified in the product’s instructions for use (IFU).
Given the cover glass can come away from the device, there is the potential for this component to fall into the patient’s airway during application.
To date, no patient injuries have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine any affected devices.
- Contact Karl Storz. to return any affected stock. A Return Material Authority (RMA) is required.
- Contact a Karl Storz. sales representative for replacement stock options.
This action has been closed out on 23/07/2026 |
| Action Commencement Date |
27/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 996 562 - Karl Storz Endoscopy |