Recall Z-1764-2025

Reason for recall

Patient monitor has nine identified cybersecurity vulnerabilities.

FDA-determined cause: Software design

Action taken

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 another Security Advisory notice once the remediation plan is finalized. Mitigations for patients and caregivers using the CMS8000 patient monitor outside a healthcare facility (i.e., in a home environment): -If the device can be safely disconnected from the internet, unplug the ethernet cable from the CMS8000 patient monitor and use only local monitoring features of the device. - If the device cannot be safely disconnected from the internet, we recommend that you stop using the CMS8000 patient monitor and contact your healthcare provider about finding an alternate patient monitor. This security Advisory notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Complete and return the response form. If you have any questions, please contact the firm at contact@contecmed.com On 5/19/2025, additional notices were distributed informing customers to contact the firm or local distributor, email at contact@contecmed.com, so they can provide a software upgrade package and installation guide.