[pending] BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Pending LLM rewrite. Source: FDA_DEVICE Z-1645-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
The recalled product
- Product
- BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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