Koninklijke Philips NV (PHIA.AE) said on Wednesday that it has agreed with the U.S. Department of Justice to suspend production and distribution of external defibrillators manufactured at its facilities in Andover, Massachusetts, and Bothell, Washington.
The Dutch health-technology company said it anticipates the suspension to have an impact of approximately 20 million euros ($23.6 million) on its earnings before interest, taxes and amortization in the fourth quarter of 2017 and of EUR60 million in 2018. Combined sales of the affected defibrillator product lines were around EUR35 million per quarter in 2016, the company added.
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Philips said the agreement was reached by its subsidiary Philips North America LLC with the Department of Justice, representing the Food and Drug Administration, and the suspension came about following inspections in and before 2015. The suspension will remain in place until the FDA certifies Philips' facilities comply with regulations, Philips added.
The company also said that its defibrillators currently in use shouldn't be taken out of service as it has no reason to believe they pose a risk to patients.
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(END) Dow Jones Newswires
October 11, 2017 01:53 ET (05:53 GMT)