Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA) announced today that its subsidiary Philips North America LLC reached agreement on a consent decree with the U.S. Department of Justice, representing the Food and Drug Administration (FDA), related to compliance with current good manufacturing practice requirements arising from past inspections in and before 2015, focusing primarily on Philips’ Emergency Care & Resuscitation (ECR) business operations in Andover (Massachusetts, U.S.) and Bothell (Washington, U.S.). The decree also provides for increased scrutiny, for a period of time, of the compliance of the other patient care businesses at these facilities with the Quality System Regulation. The decree will become effective once it is approved by the U.S. District Court for the District of Massachusetts.
Under the decree, Philips will suspend the manufacture and distribution of external defibrillators manufactured at these facilities, subject to certain exceptions, until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation. The decree allows Philips to continue the manufacture and distribution of certain automated external defibrillator (AED) models  and Philips will continue to service ECR devices and provide consumables and the relevant accessories, to ensure uninterrupted availability of these highly reliable life-saving devices in the U.S. Philips will also continue to export ECR devices once certain requirements have been met. Philips will continue to manufacture and distribute the products of the other patient care businesses at these facilities.
“We are committed to delivering high quality, innovative products and solutions, and we take this matter very seriously,” said Carla Kriwet, Chief Business Leader Connected Care & Health Informatics at Royal Philips. “We are fully prepared to fulfill the terms of the decree, and we hope to resume the suspended defibrillator production in the course of 2018. Over the last years, we have made significant investments in our Quality Management System, with the change in our company-wide quality leadership and the launch of new standards and initiatives across all our businesses and markets. We will continue this program to further enhance our quality management throughout Philips.”
Philips defibrillators currently in use by customers are recommended by Philips to remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients. Philips is proud that its defibrillators save lives daily, with a high reliability record.
The full consent decree will be posted on Philips’ website, along with information for users of Philips external defibrillators, describing how these products are impacted by the consent decree. Customers with questions not answered on Philips’ website, can also contact Philips at + 1 800 263 3342 or via this link.