Recall Z-1764-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Contec Medical Systems Co., Ltd.
CMS8000 Patient Monitor
| Date | May 14, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Patient monitor has nine identified cybersecurity vulnerabilities. |
| Root cause | Software design |
| Action | On 4/10/2025, Security Advisory Notices were sent to customers who were asked to do the following: Immediate Mitigation Actions: 1) Network segmentation. a. Implement Segmentation: Segment your network to isolate the device from other parts of the network. b. Use Firewalls: Utilize firewalls to control and monitor traffic between different segments, ensuring only authorized communications are allowed. 2) Disable the monitor network port to protect it from potential network threats. Long term mitigation action: Firm is in the process of finalizing a remediation plan and will follow-up with an |
| Quantity | 7773 |
| Distribution | US Nationwide distribution in the states of CA, IL, FL, KY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101692 | PATIENT MONITOR Contec Medical System Co., Ltd., Jun 28, 2011 |