| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00527-1 |
| Product Name/Description |
Connex Spot Monitor
Multiple Products and Product Codes
ARTG 340035
(Welch Allyn Australia Pty Limited - Connex Spot Monitor - Multiple physiological parameter spot-check analysis system, clinical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Baxter is providing a fix for a security vulnerability that has been found involving the Connex Spot Monitor (CSM).
Baxter offered a routine software enhancement to address the vulnerability on 16 October 2023 under software patch version 1.52.01. The software patch includes additional controls for accessing the Advanced Settings and Debug Menu.
These tools on the device require additional authentication to prevent access to the default key.
To reduce the security risk, Baxter has issued a firmware update v1.52.01.
The affected software versions are all prior to and including CSM 1.52.00. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. Customers are to upgrade CSM devices to firmware v1.52.01 and follow the workarounds to help reduce the risk:
- Apply proper network and physical security controls.
- Ensure a unique encryption key is configured and applied to the product (as described in the Welch Allyn Connex Spot Monitor Service Manual, Page 127).
2. Customers can access v.1.52.01 via Welch Allyn Service Tool and through Smart Care Remote Management. |
| Contact Information |
1800 445 576 - chris_dee@baxter.com - Baxter Healthcare |