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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Contec CMS8000 Patient Monitors Recalled for Cybersecurity Vulnerabilities

Agency Publication Date: May 14, 2025
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Summary

Contec Medical Systems Co., Ltd. is recalling 7,773 CMS8000 Patient Monitors due to nine identified cybersecurity vulnerabilities. These flaws could potentially allow unauthorized users to access the device remotely, which could lead to the manipulation of patient health data or disruption of the monitor’s performance. These devices were distributed across the United States, including in California, Illinois, Florida, Kentucky, and Texas. No incidents or injuries have been reported, and Contec is coordinating with distributors to secure or correct the affected units.

Risk

The cybersecurity vulnerabilities could allow an attacker to gain access to the device's operating system or network. This unauthorized access could allow a user to change settings or data, potentially resulting in incorrect patient monitoring or delayed clinical interventions.

What You Should Do

  1. This recall involves Contec CMS8000 Patient Monitors with the UDI-DI code 06945040100034 and specific serial numbers including various AX-prefixed codes and long UDI-based identifiers.
  2. Check the label on your patient monitor to verify if the model name is CMS8000 and confirm if your serial number matches the affected list. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Contec Medical Systems Co., Ltd. or your medical equipment distributor to arrange for a device correction, replacement, or return.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CMS8000 Patient Monitorby Contec
Model / REF:
CMS8000
Serial Numbers (384):
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
UDI:
06945040100034

Patient monitor affected by nine identified cybersecurity vulnerabilities.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96046
Status: Active
Manufacturer: Contec Medical Systems Co., Ltd.
Sold By: medical equipment distributors
Manufactured In: China
Units Affected: 7773
Distributed To: California, Illinois, Florida, Kentucky, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.