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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmApril 10, 2025
Create DateMay 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1764-2025
Recall Event ID 96046
ProductCMS8000 Patient Monitor
Recalling Firm/
Manufacturer		 Contec Medical Systems Co., Ltd.
Economic And
No. 112 Qinhuang West Street; Technical Development Zone
Qinhuangdao China
For Additional Information Contact
335-8015430
Manufacturer Reason
for Recall		Patient monitor has nine identified cybersecurity vulnerabilities.
ActionOn 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.
Quantity in Commerce7773
DistributionUS Nationwide distribution in the states of CA, IL, FL, KY, TX.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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