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February 2, 2025

FDA Warns of Cybersecurity Risks in Contec and Epsimed Patient Monitors

MedTech Dive
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Contributed by: Kate Gamble
Summary
The FDA has issued a safety communication regarding cybersecurity vulnerabilities in Contec's CMS8000 patient monitors and Epsimed's MN-120 product line, which could allow unauthorized access and manipulation of the devices used for monitoring patients' vital signs. The vulnerabilities, identified as high severity by the Cybersecurity and Infrastructure Security Agency (CISA), could enable attackers to control the monitors remotely, potentially compromising patient safety by affecting device functionality and data integrity. Although no incidents of harm or data breaches have been reported, the FDA is advising patients, healthcare providers, and IT personnel to adopt precautionary measures to mitigate associated risks.

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