[pending] CMS8000 Patient Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1764-2025.
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
Patient monitor has nine identified cybersecurity vulnerabilities.
The recalled product
- Product
- CMS8000 Patient Monitor
- Manufacturer
- Contec Medical Systems Co., Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187
- AX1412300128 AX1412300034 AX1412300172
- AX142200158 AX142200013
Distribution
Distributed nationwide across the United States.
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