Alaris System Infusion Pumps_cfn San Diego

Recalling firm
Becton Dickinson Ltd
Product
Alaris System Infusion Pumps_CFN San Diego. [Device]. Model: BD Alaris™ Point of Care Unit (PCU). Affected: Software - 12.1.1
Reason
The manufacturer has identified that the device labelling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the AlarisTM 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., Alaris™ and BD Alaris™ PCUs (v12.1.1 and prior) are not compatible with TLS security frameworks beyond TLS 1.0. If TLS 1.0...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-09-24
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/6343941c-b32d-4148-85c3-207c8342c824