FDA Cybersecurity Safety Communication – Hospira

FDA issued a safety communication to health care facilities using the Hospira Symbiq Infusion System regarding cybersecurity vulnerabilities. FDA is advising facilities to seek alternative infusion systems. In the interim, it is recommended the systems be disconnected from networks and maintain the drug libraries by updating manually along with other recommendations.

An article regarding the flaw can be found at: https://www.reuters.com/article/us-hospira-fda-cybersecurity-idUSKCN0Q52GJ20150731.

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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