Medical device recalls Moderate risk

Contec Medical Systems Co., Ltd. recalls CMS8000 Patient Monitor

Recall date
April 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1764-2025
FDA classification
Class II
Brand / firm
Contec Medical Systems Co., Ltd.
Sold / distributed
US Nationwide distribution in the states of CA, IL, FL, KY, TX.

Why it was recalled

Patient monitor has nine identified cybersecurity vulnerabilities.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CMS8000 Patient Monitor

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