Safety alert: LifeCare PCA3 and PCA5 infusion pump systems by Hospira

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The FDA and Hospira have become aware of security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems. An independent researcher has released information about these vulnerabilities, including software codes, which, if exploited, could allow an unauthorized user to interfere with the pump’s functioning. An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. The FDA is not aware of any patient adverse events or unauthorized device access related to these vulnerabilities.

The FDA is actively investigating the situation based on current information and close engagement with Hospira and the Department of Homeland Security. As new information becomes available about patient risks and any additional steps usersshould take to secure these devices, the FDA will communicate publicly.

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