FDA reaches agreement with automatic external defibrillator maker

A permanent injunction was issued to prevent Philips North America and related companies to prevent their production and sale of AED devices made at two facilities until they comply with FDA regulations.
By Amy Wallace  |  Nov. 2, 2017 at 11:35 AM
share with facebook
share with twitter

Nov. 2 (UPI) -- The U.S. Food and Drug Administration has been granted a permanent injunction this week against a company that markets automatic external defibrillators.

U.S. District Judge Denise J. Casper entered a consent decree of permanent injunction between the U.S. and Philips North America LLC, doing business as Philips Medical Systems and Philips Healthcare of Andover, Mass.

The decree prohibits the company and two of the company's officers, Carla Kriwet and Ojas Buch, from making, processing, packing, holding or distributing devices made by the company's Emergency Care and Resuscitation unit until they comply with the Federal Food, Drug and Cosmetic Act and FDA regulations.

The company was accused of the manufacture and sale of adulterated devices whose AEDs and Q-CPR Meters were made in violation of the FD&C Act and current good manufacturing practices.

"AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency," Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in a press release.

"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."

Related UPI Stories
Trending Stories