FDA Issues Recall on Pacemakers Due to Security Vulnerabilities

FDA Issues Recall on Pacemakers Due to Security Vulnerabilities

The FDA issued a security advisory, warning that the pacemakers must be recalled on a voluntary basis. The devices are much “smarter” than previous models, opening up the possibilities of being tampered with by cyber criminals.

Pacemakers by Abbott (formerly St. Jude Medical) have been recalled by the U.S. Food and Drug Administration due to security vulnerabilities – prompting an estimated 465,000 patients with heart conditions across the country to need to visit their doctor to have theirs updated.

The FDA issued a security advisory, warning that the pacemakers must be recalled on a voluntary basis. The devices are much “smarter” than previous models, opening up the possibilities of being tampered with by cyber criminals.

The pacemakers need to be given a firmware update to protect them against vulnerabilities which could drain battery life, allow hackers to change programmed settings or even change its beats and rhythm.

This poses a problem – seeing as the recalled devices are embedded in patients’ chests.

In a letter sent to doctors, Abbott admitted that the update, approved by the FDA on August 23, could not be delivered over the air and will require about three minutes in the presence of the patient to download and install while in backup mode.

Patients are asked to contact their doctors to book themselves an appointment to get the update. However, in the letter, doctors are advised by Abbott to update only if it is "appropriate given the risk of update for the patient."

Patients with a RF-enabled St. Jude pacemaker or cardiac pacemaker, as well as healthcare professionals who are using these devices presently in hospitals to treat conditions including heart failure and irregular heart rhythms, must make sure a firmware update is applied to these devices. This specifically includes the Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure models.

"The FDA reminds patients, patient caregivers, and health care providers that any medical device connected to a communications network (e.g. Wi-Fi, public or home Internet) may have cybersecurity vulnerabilities that could be exploited by unauthorized users," the FDA said in its announcement. "However, the increased use of wireless technology and software in medical devices can also often offer safer, more efficient, convenient, and timely health care delivery."

Featured

New Products

  • Camden CV-7600 High Security Card Readers

    Camden CV-7600 High Security Card Readers

    Camden Door Controls has relaunched its CV-7600 card readers in response to growing market demand for a more secure alternative to standard proximity credentials that can be easily cloned. CV-7600 readers support MIFARE DESFire EV1 & EV2 encryption technology credentials, making them virtually clone-proof and highly secure.

  • Automatic Systems V07

    Automatic Systems V07

    Automatic Systems, an industry-leading manufacturer of pedestrian and vehicle secure entrance control access systems, is pleased to announce the release of its groundbreaking V07 software. The V07 software update is designed specifically to address cybersecurity concerns and will ensure the integrity and confidentiality of Automatic Systems applications. With the new V07 software, updates will be delivered by means of an encrypted file.

  • Mobile Safe Shield

    Mobile Safe Shield

    SafeWood Designs, Inc., a manufacturer of patented bullet resistant products, is excited to announce the launch of the Mobile Safe Shield. The Mobile Safe Shield is a moveable bullet resistant shield that provides protection in the event of an assailant and supplies cover in the event of an active shooter. With a heavy-duty steel frame, quality castor wheels, and bullet resistant core, the Mobile Safe Shield is a perfect addition to any guard station, security desks, courthouses, police stations, schools, office spaces and more. The Mobile Safe Shield is incredibly customizable. Bullet resistant materials are available in UL 752 Levels 1 through 8 and include glass, white board, tack board, veneer, and plastic laminate. Flexibility in bullet resistant materials allows for the Mobile Safe Shield to blend more with current interior décor for a seamless design aesthetic. Optional custom paint colors are also available for the steel frame.