FDA Recalls Pacemakers Over Fear of Hackers - NBC 6 South Florida
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FDA Recalls Pacemakers Over Fear of Hackers

The FDA said there have been no reports of unauthorized access to any patient's implanted device



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    In this June 21, 2006 file photo, Dr. George Sawaya examines patient Susan Lehr at the UCSF Women's Health Center in San Francisco, California.

    The Food and Drug Administration is recalling 465,000 pacemakers over fears that they could be hacked.

    The pacemakers are to be uploaded with new secure software after the FDA discovered cybersecurity vulnerabilities that would allow a hacker to take over the medical device that controls the heart.

    Pacemaker brands from Abbott -- the Accent, Anthem, Accent MRI, Accent ST, Assurity, and Allure -- are included in the recall.

    Patients do not need another surgery. The FDA said the recall requires an in-person patient visit with a health-care provider. An update of the firmware, the device's permanent software, will take approximately 3 minutes to complete.

    According to the FDA, while the pacemaker is being updated, it will operate in backup mode, pacing at 67 beats per minute, and essential, life-sustaining features will remain available. At the completion, the device will return to its pre-update settings.

    "To further protect our patients, Abbott has developed new firmware with additional security measures that can be installed on our pacemakers," said Robert Ford, an Abbot executive vice president for medical devices, in a statement about the update. 

    The FDA approved the firmware update last week.

    Cybersecurity concerning patients' medical devices and their associated computers, networks, programs, and data focuses on protecting them from unintended or unauthorized access, change, or destruction.

    The FDA said there have been no reports of unauthorized access to any patient's implanted device, and according to an advisory issued by the U.S. Department of Homeland Security, compromising the security of the devices would require a highly complex set of circumstances.