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FDA warns medical device is vulnerable to cybersecurity threat

The device is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population.

The FDA is warning that the Symbiq Infusion System could potentially be vulnerable to a cybersecurity attack, and is encouraging healthcare professionals to use alternative infusion systems, and discontinue use of these pumps.

Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a hospital’s network, according to the FDA. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.

The FDA and Hospira are currently not aware of any patient adverse events or unauthorized access of a Symbiq Infusion System in a health care setting.

Hospira has discontinued the manufacture and distribution of the Symbiq Infusion System, due to unrelated issues, and is working with customers to transition to alternative systems. However, the FDA is aware that the Symbiq Infusion System is potentially available for purchase from third parties not associated with Hospira. The FDA strongly discourages the purchase of the Symbiq Infusion System from these parties.

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