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FDA Announces First-Ever Recall of a Medical Device Due to Cyber Risk

FDA Announces First-Ever Recall of a Medical Device Due to Cyber Risk
This week, the FDA took the unprecedented step of recalling a medical device – a pacemaker – because it was found to be vulnerable to cyber threats. The recall arose from an investigation by the FDA in February that highlighted a number of areas of non-compliance. While there are no known reports of patient harm related to the implanted devices affected by the recall, the step was taken as a preventative measure. A firmware update has been developed (and approved by the FDA) that can be applied during a patient visit with their healthcare provider.
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FDA Announces First-Ever Recall of a Medical Device Due to Cyber Risk

31 Aug 2017
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  • Internet of Everything, Digital Business, Healthcare, Security

FDA Announces First-Ever Recall of a Medical Device Due to Cyber Risk

Source: Richard Staynings

This week, the FDA took the unprecedented step of recalling a medical device – a pacemaker – because it was found to be vulnerable to cyber threats. The recall arose from an investigation by the FDA in February that highlighted a number of areas of non-compliance. While there are no known reports of patient harm related to the implanted devices affected by the recall, the step was taken as a preventative measure. A firmware update has been developed (and approved by the FDA) that can be applied during a patient visit with their healthcare provider.

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