Philips Agrees to Safety Oversight and Penalties to Resolve Device Recall Issues
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Philips must hire an independent safety monitor, undergo inspections, and pay the government under a consent decree related to its device recall.
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The company is prohibited from selling certain devices in the U.S. and must turn over up to 25% of revenue from some devices.
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Philips did not admit fault but the government said the company sold "adulterated" devices.
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If Philips violates the agreement, it could pay up to $20 million per year.
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The impact on patient health from the recalled devices will take years to fully assess, though cancer and other illnesses have been reported.