CMS8000 Patient Monitor Has Nine Cybersecurity Vulnerabilities
The CMS8000 Patient Monitor manufactured by Contec Medical Systems Co., Ltd. has nine identified cybersecurity vulnerabilities. The FDA is issuing this Class II recall affecting approximately 7,773 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving cybersecurity vulnerabilities without any reported illnesses or injuries. The hazard is theoretical rather than confirmed, placing it within the Moderate category per the rubric.
Plain-English summary
Contec Medical Systems Co., Ltd. is recalling the CMS8000 Patient Monitor due to nine identified cybersecurity vulnerabilities. The device has been distributed nationwide in California, Illinois, Florida, Kentucky, and Texas. Approximately 7,773 units are affected by this recall.
The vulnerabilities could potentially allow unauthorized access or manipulation of the device. However, the source text does not report any confirmed illnesses, injuries, or adverse events related to these vulnerabilities to date.
Affected patients and healthcare facilities should contact Contec Medical Systems Co., Ltd. or consult the FDA recall notice for guidance on remediation steps. The device model CMS8000 with UDI-DI 06945040100034 and specific serial numbers listed in the recall are included in this action.
The recalled product
- Product
- CMS8000 Patient Monitor
- Manufacturer
- Contec Medical Systems Co., Ltd.
- Hazard
- cybersecurity-vulnerability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187
- AX1412300128 AX1412300034 AX1412300172
- AX142200158 AX142200013
Distribution
Distributed nationwide across the United States.
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