Contec Medical Systems Co., Ltd.: Device Recall

Recall #Z-1764-2025 · 04/10/2025

Class II: Risk

Recall Details

Recall Number
Z-1764-2025
Classification
Class II
Product Type
Device
Recalling Firm
Contec Medical Systems Co., Ltd.
Status
Ongoing
Date Initiated
04/10/2025
Location
Qinhuangdao, China
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7773

Reason for Recall

Patient monitor has nine identified cybersecurity vulnerabilities.

Product Description

CMS8000 Patient Monitor

Distribution Pattern

US Nationwide distribution in the states of CA, IL, FL, KY, TX.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.