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Sunday
Sep032017

FDA recalls more than 400K pacemakers due to hacking concerns

iStock/Thinkstock(NEW YORK) -- The Food and Drug Administration is warning the public that more than 400,000 pacemakers in the U.S. are in danger of being hacked.

The agency issued an alert stating that the company producing these pacemakers -- Abbott, formerly known as St. Jude Medical -- is taking "corrective" action.

The voluntary recall affects 465,000 radio frequency-enabled implantable pacemakers. It covers several models, including Allure, Accent, Anthem, Accent MRI, Accent ST and Assurity.

“The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment,” the FDA said.

“This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing."  

The FDA said there aren't any known reports of patient being harmed because of cybersecurity issues in the software.

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