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 US, the consent decree included exemptions for specific Philips Automated External Defribrillator (AED) models to continue to be manufactured and shipped, in addition to providing necessary device servicing, accessories and consumables.
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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.
“The injunction lift is an important milestone for Philips, as we have enhanced the regulatory compliance processes in our ECR business and throughout the company,” said Frans van Houten, CEO of Royal Philips. “Providing our customers with safe and reliable products and solutions remains our highest priority, and I am proud that our AEDs save lives daily, with their very high reliability record.”