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Philips to halt U.S. production of defibrillators

Philips defibrillators
Technology   The Quality System Regulation

Royal Philips announced that its subsidiary Philips North America reached agreement on a consent decree with the U.S. Department of Justice, representing the Food and Drug Administration (FDA).

This is 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.


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