December 16, 2019
Thus far, regulatory guidance for medical device cybersecurity has been focused on the approval or compliance of the device itself and has not been very specific about what cybersecurity assurance information is provided to the health care customers that host the devices within their IT infrastructure.  Medical device labeling has been sparse related to cybersecurity...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 12/16/2019 Class I PRODUCT Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. Recall Number: Z-0610-2020 REASON There is an anomaly in...
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