FDA lifts injunction on manufacture and distribution of Philips’ defibrillators in the US
Koninklijke Philips N.V. NY Registry Shares (PHG)
US:NYSE Investor Relations:
philips.com/a-w/about/investor.html
Company Research
Source: GlobeNewswire
April 24, 2020 Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced today that its Emergency Care and Resuscitation (ECR) business is resuming manufacturing and shipping of external defibrillators for the US, following notification from the US Food and Drug Administration (FDA) that the injunction prohibiting those activities has been lifted. 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 manufactu
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PHG
Earnings
- 11/4/25 - Miss
PHG
Sec Filings
- 11/4/25 - Form 6-K
- PHG's page on the SEC website