| TGA Action ID |
RC-2025-RN-00435-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HotDog Patient Warming Mattress
Model numbers: U1XX, U2XX, U3XX
All serial numbers |
| ARTG Number |
198956 |
| Unique Device Identifier (UDI) |
HotDog Patient Warming Mattress |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a risk of injury to users if appropriate mitigation measures are not implemented to prevent pressure injuries when using the HotDog Patient Warming Mattress.
In response to an incident reported to the TGA, the manufacturer has updated the instructions for use (IFU). The updates do not change any of the existing use instructions, but instead further clarify and/or emphasise certain points in the IFU. |
| Instructions for Customers/Users |
Customers are to discard existing versions of the IFU and replace them with the updated version (P/N 2064AU Rev A) provided with the customer letter. Ensure all staff members who use the HotDog Patient Warming Mattress are aware of the updated IFU and are familiar with all existing and additional Warnings and Precautions.
This action has been finalised on 17/9/2025. |
| Action Commencement Date |
6/05/2025 |
| Responsible Entity |
|
| Contact Information |
1300 144 734 - Lateral Medical |