FDA Device recall Z-1764-2025
CMS8000 Patient Monitor
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of CMS8000 Patient Monitor by Contec Medical Systems, citing patient monitor has nine identified cybersecurity vulnerabilities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1764-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-10 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Contec Medical Systems |
| Distribution | US |
Product
CMS8000 Patient Monitor
Reason
Patient monitor has nine identified cybersecurity vulnerabilities.
Identifiers
| code_info | UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187, AX1410100001 AX1410100014 AX1410100015 AX1410100024 AX1…UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187, AX1410100001 AX1410100014 AX1410100015 AX1410100024 AX1410100028 AX1410100030 AX1410100036 AX1410100037 AX1410100038 AX1410100042 AX1410100044 AX1410100050 AX1410100059 AX1410100065 AX1410100074 AX1410100078 AX1410100079 AX1410100084 AX1410100087 AX1410100088 AX1410100092 AX1410100099 AX1410100101 AX1410100105 AX1410100107 AX1410100113 AX1410100117 AX1410100122 AX1410100127 AX1410100129 AX1410100136 AX1410100137 AX1410100141 AX1410100149 AX1410100153 AX1410100157 AX1410100160 AX1410100165 AX1410100168 AX1410100170 AX1410100172 AX1410100174 AX1410100187 AX1410100189 AX1410100195 AX1410100199 AX1411100003 AX1411100004 AX1411100006 AX1411100007 AX1411100008 AX1411100009 AX1411100011 AX1411100015 AX1411100018 AX1411100020 AX1411100024 AX1411100026 AX1411100027 AX1411100032 AX1411100038 AX1411100040 AX1411100042 AX1411100043 AX1411100044 AX1411100054 AX1411100057 AX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1764-2025%22
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