Philips Falls Under FDA Scrutiny Over Heart Defibrillators
- Dutch company discloses U.S. ‘civil matter’ over equipment
- Philips CEO says there’s no lawsuit; relation to 2013 warning
Philips CEO: U.S. Is Important, Uncertainty a Concern
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Royal Philips NV’s health-equipment business in the U.S. has come under renewed scrutiny after the Dutch company disclosed a conflict with authorities over its heart defibrillators more than three years after the Food and Drug Administration warned about their reliability.
Philips is in talks with the Department of Justice, representing the FDA, on a civil matter related to inspections of the devices leading up to 2015, the Amsterdam-based company said in a statement Tuesday. As a result, the company said it’s expecting a “meaningful impact” on the operations of the business, which has annual worldwide sales of about 290 million euros ($312 million), half from the U.S.