Nearly a quarter of recalls are due to a software failure, FDA says. The testing increase is needed to prevent injury or death as a result of software that has been poorly designed or written poorly. Google reported blocking a malware riddled Web site that distributed software updates for a wide-range of medical equipment. The risk has increased as devices are being designed and operated as special purpose computers. Many of these devices are connected to networks that could be vulnerable to malware attacks, experts say. In 2008, the FDA started building a national electronic safety system designed to monitor medical devices.”]
Source: https://www.csoonline.com/article/2131903/fda-eye-on-medical-device-software-after-recall-link.html