| TGA Action ID |
RC-2026-RN-00577-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
McGRATH MAC video laryngoscope
Catalogue Number: 11996-000393
All serial numbers before 366170
ARTG 257433 (Cancelled 26/07/2024) |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Medtronic have reported that the battery management system within the devices being removed (McGRATH MAC EMS Video Laryngoscope device, catalogue number 300-200-000; supplied under Stryker Catalogue number 11996-000393) is not sufficient to mitigate against depletion of the battery voltage below the design threshold.
Batteries that are depleted below the design threshold may increase the risk of the battery becoming unstable, which may lead to a thermal event followed by a risk of explosion. |
| Instructions for Customers/Users |
Customers are to:
- Immediately discontinue use of devices being removed.
- Uninstall and dispose of the battery assembly from the device/s
- A refund will be issued by Stryker for any affected devices on hand once the completed Response Form has been returned to postmarketssp@strkyer.com. |
| Action Commencement Date |
30/07/2026 |
| Responsible Entity |
|
| Contact Information |
+61 437 112 648 - Avalon Grygorcewicz or postmarketssp@stryker.com |