In a major blow to Philips, the company announced that it could be years before it can resume sales of its recalled breathing machines. The devices, manufactured in two factories outside Pittsburgh, have been at the center of controversy due to concerns over their safety.

The halt in sales comes as part of a multiyear consent decree negotiated with the Department of Justice on behalf of the Food and Drug Administration (FDA). Philips stated that all conditions of the agreement must be met before they can start selling the machines again.

The decision to halt sales follows relentless criticism and a ProPublica and Pittsburgh Post-Gazette investigation that revealed the company had withheld thousands of complaints about the machines' faulty foam for over a decade. This delay in addressing the dangers of the foam put vulnerable individuals, including infants, the elderly, veterans, and patients with chronic conditions, at risk.

Former users of the recalled machines expressed relief upon hearing the news. Richard Callender, a former mayor in Pennsylvania who used one of the machines, remarked, "How many people have to suffer and get sick and die?" It is unclear how the sales halt will impact patients and doctors, as Philips held a significant market share for sleep apnea devices in the U.S. in 2020.

The settlement agreement, which is still being finalized and awaiting court approval, includes various requirements that Philips must fulfill before resuming sales. This includes meeting the standards for the marquee device, DreamStation 2, a CPAP machine used for sleep apnea treatment.

While Philips did not address the safety concerns of the recalled devices in their announcement, they have previously claimed that new testing demonstrated the foam caused no significant harm to patients. However, the FDA disagreed, deeming the company's tests inadequate.

This recent development comes on the heels of federal lawmakers calling for a criminal investigation into Philips and the Government Accountability Office initiating an inquiry into the FDA's oversight of medical device recalls.

The recall of Philips breathing machines sparked a global health emergency, leaving millions of patients scrambling to find alternative machines and assess the potential long-term risks. Philips has discontinued some of the recalled devices, including ventilators and the DreamStation Go portable CPAP.

The company assured customers that ongoing service and parts support would be provided for machines already in use, and sales of devices outside the United States would continue, subject to the requirements of the agreement.

Philips' CEO, Roy Jakobs, acknowledged the distress and concern caused and emphasized the company's commitment to complying with the consent decree.

The fallout from this massive recall has not only affected Philips' reputation but has also raised questions about the trust placed in the industry leader. Dr. Radhika Breaden, a sleep medicine specialist, expressed disappointment, stating, "They have lost the trust of many of our sleep patients and many professionals in the sleep field."

As the settlement awaits finalization and approval, Philips faces an uphill battle to regain its market position and rebuild trust among customers and medical professionals.