FDA recalls 500,000 pacemakers in the US for a critical safety breach



 
The FDA, the US Federal Food and Drug Administration, announced the recall of half a million pacemakers at risk of piracy that could lead to the death of the carrier.



An X-ray of a pacemaker in someone's chest. (Photo via wikimedia.org)
 Medical devices and prostheses connected are regularly pointed at the negligence of manufacturers about the security of embedded software. And the FDA (Food & Drug Administration) has just denounced the situation by organizing the recall of more than 500,000 pacemakers who present a risk of piracy.

The pacemakers in question are supposed to monitor the wearer's heart rhythm and correct the disorders in the wearer by stimulating the muscle with electrical discharges. These are pacemakers developed by the company St Jude Medical that would present a major flaw in their firmware that would allow remote control.


A hacker could then influence the patient's heart rate or exhaust the battery of the module to make it unusable.


Fortunately, the manufacturer of these devices has provided the possibility of updating the firmware of its pacemakers through a radio connection. Patients will not be required to undergo a new surgical procedure, however, they are strongly advised to contact the FDA to learn how to take advantage of a patch.


Nevertheless, the updating procedure is not without risks. When rewriting the firmware, the pacemaker can see the diagnostic data disappear or the procedure can lead to blocking of the device which would then involve surgery to replace it.


This case proves once again the urgent need for manufacturers of connected medical devices to take more seriously the security of their devices.



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