| TGA Action ID |
RC-2026-RN-00720-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BD Alaris Point of Care Unit (PCU) Wireless ONLY
Model Number: 8015
Software Version: 12.1.1 |
| ARTG Number |
146664 |
| Unique Device Identifier (UDI) |
10885403515231, 10885403516023, 10885403519215, 10885403519284, 10885403519291 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Device labelling does not indicate that Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the Alaris and BD Alaris Point-of-Care Unit (PCU) when using enterprise-level Wi-Fi security.
Without clear labelling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential System Error. |
| Instructions for Customers/Users |
BD is updating its product labelling for actively installed versions of Systems Manager to clarify compatibility requirements related to TLS protocols to ensure customers can appropriately configure their networks. |
| Action Commencement Date |
23/09/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 8875 7000 - BD |