US Election 2024

Florida AG subpoenas Chinese medical device maker over ‘compromised’ products

Florida’s Republican Attorney General James Uthmeier has taken a bold step this week by filing legal action against Chinese medical device manufacturer Contec Medical Systems Co., Ltd. The company is accused of selling compromised medical devices that pose serious cybersecurity risks, including a “backdoor” that could potentially be exploited by bad actors. The state AG’s office served subpoenas to Contec this week, alleging violations of state consumer protection laws.

The specific device in question is the CMS800 patient monitoring device, which has been flagged by the Cybersecurity and Infrastructure Security Agency (CISA) and the U.S. Food and Drug Administration (FDA) for potential security vulnerabilities. Concerns have been raised about a built-in backdoor that could allow unauthorized access to patient data and automatic transmission of information to an IP address in China.

Uthmeier’s press release highlighted the serious nature of the security issues surrounding Contec’s devices, pointing out that the FBI has warned of cyber threats targeting American healthcare systems. Federal agencies have recommended that these monitors be disconnected or disabled to prevent potential breaches.

Contec and one of its distributors, Epsimed based in Miami, have been accused of misrepresenting the devices as FDA-approved and meeting international standards when they do not. Epsimed allegedly relabeled Contec’s devices as their own, hiding the true origin of the products from consumers. Uthmeier also issued subpoenas to Epsimed, urging cooperation in the investigation.

While Contec has not responded to requests for comment, Epsimed’s CEO Jose Mena confirmed receipt of the subpoenas and stated that they are fully cooperating with the investigation. Mena clarified that the monitors are primarily used in Latin America and are not connected to the internet, mitigating potential security risks.

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Uthmeier’s legal action is the first step in a process that could result in damages, civil penalties, or injunctive relief against the companies involved. This move comes amidst growing concerns about Chinese companies’ influence and control over critical infrastructure in the United States, raising national security implications.

Security expert Michael Lucci emphasized the importance of protecting patient data from being transmitted to foreign entities like Communist China. Patients should feel secure in knowing that their medical devices are not compromising their privacy and safety. Uthmeier’s efforts to hold Contec accountable for their alleged security flaws reflect a commitment to safeguarding American healthcare systems from cyber threats.

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