Class II — Contec Medical Systems Co., Ltd.
| Recalling firm | CONTEC MEDICAL SYSTEMS CO., LTD |
|---|---|
| Registered facility | CONTEC MEDICAL SYSTEMS CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Patient monitor has nine identified cybersecurity vulnerabilities. |
| Product | CMS8000 Patient Monitor |
| Quantity | 7773 |
| Distribution | US Nationwide distribution in the states of CA, IL, FL, KY, TX. |
| Initiated | 2025-04-10 |
| Classified | 2025-05-14 |
| Recall number | Z-1764-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Contec Medical Systems Co., Ltd. (Z-1764-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96046/
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