Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.
Lawyers for the federal government alleged that the company failed to comply with good manufacturing practices needed to ensure device safety. The company did not admit to the allegations, according to the court filing. Jeffrey Reed, of Marysville, Ohio, experienced persistent sinus infections and two bouts of pneumonia during the seven years he used a Philips machine.
A company spokesman said Tuesday the agreement provides"a roadmap of defined actions, milestones, and deliverables to meet relevant regulatory requirements,” in an emailed statement. He noted that Philips will still be able to export some machines for sale outside the U.S.
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