FDA recall Z-1764-2025
Contec Medical Systems Co., Ltd. · Class II · device
Product
CMS8000 Patient Monitor
Reason for recall
Patient monitor has nine identified cybersecurity vulnerabilities.
Distribution
US Nationwide distribution in the states of CA, IL, FL, KY, TX.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-04-10
- Report date
- 2025-05-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Qinhuangdao, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1764-2025