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Philips North America will halt most manufacture and sale of automated external defibrillators (AEDs) and Q-CPR Meters after violating good manufacturing practices, the FDA .
The company, which does business as Philips Medical Systems and Philips Healthcare, holds the largest market share of any maker of AEDs at about 50% of the overall global market for public access defibrillators, an FDA spokesperson told 乌鸦传媒.
"People rely on these devices to work when needed. By not adequately addressing corrective and preventive actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk," Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the agency announcement.
The U.S. Department of Justice had filed a complaint on behalf of the FDA that Philips failed to establish and maintain adequate processes regarding its corrective and preventive action procedures, design verification and validation controls, and product specifications.
The resultant consent decree requires Philips to stop operations at its two U.S. facilities for emergency care and resuscitation devices with certain exceptions, until it has a qualified third-party expert inspect quality system regulation compliance and the FDA inspects both manufacturing facilities.
A Philips spokesperson later clarified that the company will continue to service its devices and provide consumables and relevant accessories as well as ship its Q-CPR Meter with updated labeling and instructions for use.
The FDA announced in 2015 that it was to improve quality and reliability, including requiring premarket approval applications and manufacturing facility inspections, after 111 recalls affecting more than 2 million AEDs since 2005 -- many due to design and manufacturing issues.