CMS8000 Patient Monitor — Class II medical device recall Z-1764-2025
Ongoing recall by Contec Medical Systems Co., Ltd., reported 2025-05-21, distributed nationwide. Patient monitor has nine identified cybersecurity vulnerabilities.
| Recall number | Z-1764-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Contec Medical Systems Co., Ltd., Qinhuangdao, China |
| Recall initiated | 2025-04-10 |
| Classified | 2025-05-14 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 7,773 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06945040100034 |
| Serial numbers | AX1402200040, AX1402200149, AX1409100187, AX1410100001, AX1410100002, AX1410100003, AX1410100004, AX1410100005, AX1410100007, AX1410100011, AX1410100014, AX1410100015, AX1410100016, AX1410100017, AX1410100018, AX1410100019, AX1410100020, AX1410100021, AX1410100022, AX1410100024, AX1410100026, AX1410100027, AX1410100028, AX1410100029, AX1410100030 and 246 more |
Product
CMS8000 Patient Monitor
Reason for recall
Patient monitor has nine identified cybersecurity vulnerabilities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1764-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.