This business has been operating under a consent decree with the FDA since November 2017. Under the terms of the consent decree, Philips was required to suspend manufacture and distribution of its defibrillators from specific Philips facilities in the U.S., pending FDA certification via inspection of the facilities’ compliance with Quality System Regulation. However, in order to ensure uninterrupted availability of these life-saving devices in the U.S., the consent decree included exemptions for specific Philips Automated External Defibrillator (AED) models to continue to be manufactured and shipped, in addition to providing necessary device servicing, accessories and consumables. Philips continues to comply with the terms of the consent decree, which remains in effect, and includes ongoing regulatory compliance monitoring and facility inspections of the ECR business and of Philips’ other patient care businesses by the FDA.
On April 24, 2020, Philips announced that its Emergency Care and Resuscitation (ECR) business may resume manufacturing and shipping of external defibrillators for the U.S., following notification from the U.S. Food and Drug Administration (FDA) that the injunction prohibiting those activities has been lifted.
A consent decree is a court order issued by a federal judge with terms agreed to in advance by the U.S. government and the defendants. A consent decree typically includes injunctive provisions ordering that the defendants take or refrain from taking certain actions, with the defendants subject to court-imposed sanctions if they fail to do so.
The government sought a Consent Decree from Philips due to issues raised by regulators primarily concerning Emergency Care & Resuscitation (ECR) manufacturing practices at our Andover, Massachusetts and Bothell, Washington sites. The Decree includes provisions covering other Patient Care & Monitoring Solutions (PCMS) businesses at these two facilities. FDA communicated its concerns regarding Philips' compliance with the Good Manufacturing Practices (GMP) requirements of the Food Drug and Cosmetic Act, focusing on how Philips addressed quality issues with specific components of Philips defibrillators (including the R92 resistor).
It is important to understand that Philips defibrillators and other products manufactured by the affected business remain in use by customers, have strong reliability records and should not be taken out of service. Philips HeartStart public access AEDs shipped since January 2013 have a reliability record of approximately 99.9% per year.
The Consent Decree will remain in effect for a minimum of five years following the lifting of the injunction. After five years, if Philips has been in continuous compliance with FDA’s laws and regulations for that period, Philips may petition the United States District Court that had entered the order to vacate the injunction. During this five-year period, FDA may inspect at its sole discretion. At least once a year, Philips is required to have a third-party auditor inspect the ECR facilities covered by the decree and submit their reports to both FDA and Philips.
Customer inquiries Please contact: ecr.communications@philips.com
Media inquiries Please contact the Philips Group Press Office: Mario Fante +1 (603) 560 - 9226 Steve Klink + 31 6 108 888 24
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