FDA Announces First-Ever Recall of a Medical Device Due to Cyber Risk
Internet of Everything, Digital Business, Healthcare, Security
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.