| TGA Action ID |
RC-2025-RN-00348-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Welch Allyn Connex Devices
Welch Allyn Connex Vital Signs Monitor (CVSM)
Serial number: All
Multiple product codes
Welch Allyn CP150 Electrocardiograph
Serial number: All
Multiple product codes
Welch Allyn Connex Spot Monitor Accessory Power Management Stand (APM)
Serial number: All
Product code: 7000-APM
ARTG 220693, 327826, 340035 |
| ARTG Number |
220693, 327826, 340035 |
| Unique Device Identifier (UDI) |
Refer to Attachment B and customer letter. |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Baxter Healthcare Corporation received reports of devices experiencing battery-related fires. Investigation found that the devices in question were utilising third-party, after-market batteries that are not approved by Baxter.
The use of an unapproved batteries may lead to combustion, fire or device performance problems. |
| Instructions for Customers/Users |
Baxter will update the IFUs and service manuals to include instructions to only use a Baxter approved battery for replacement and highlight the risks associated with using an unapproved battery.
Customers are to:
1. Use only approved batteries
2. Inspect all devices for the correct battery type
3. See attachment A in the customer letter for the updated IFU wording.
This action has been finalised on 9/11/2026. |
| Action Commencement Date |
31/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 445 576 - Baxter Healthcare Customer Service |