WASHINGTON (Legal Newsline) — The U.S. Department of Justice announced Oct. 31 that Philips North America LLC and two company executives have been banned by a federal court from distributing certain medical devices.
“The Department of Justice is committed to protecting consumers and patients by ensuring that medical device manufacturers comply with the law,” said acting assistant attorney general Chad A. Readler of the Justice Department’s Civil Division.
“When a company fails to comply with legally required manufacturing standards, patients may be put at risk. The Department of Justice is committed to working with FDA to prevent these violations.”
According to allegations, the defendants failed to put in place proper procedures for corrective and preventative action for complains about its HeartStart HS1 and FRx defibrillators.
“AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk.”