The Netherlands – Philips Respironics a leading health technology company, has announced that it will on Monday halt sales of all it’s breathing machines within the United States, following a recall that started gaining momentum in mid-2021.

The machines encompass continuous positive airway pressure (CPAP) devices utilized by individuals with sleep apnea and ventilators employed by other patients. The recall stemmed from reports in 2021 detailing defective CPAP machines emitting bits of foam and potentially toxic gases into users’ airways.

Philips Respironics offers innovative products for sleep and home respiratory care as well as medical education and value-added programs to help people navigate a rapidly changing industry landscape, and in the interest of maximizing both clinical and business success.

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During that period, Philips initiated a recall of the devices in June 2021, temporarily halting sales of new sleep therapy machines to U.S. customers, as conveyed by Philips spokesman Steve Klink to the New York Times.

Subsequently, Philips released data from follow-up testing, asserting that the devices were “not expected to result in appreciable harm to health in patients,” despite ongoing testing. The U.S. Food and Drug Administration challenged the validity of these claims, deeming them “unpersuasive,” according to the Times.

The 2021 recall impacted approximately 15 million devices produced since 2006, with over 5 million believed to still be in use by 2021, according to the Times.

Numerous U.S. patients and their families, who utilized the breathing machines, have filed lawsuits against Philips, attributing the faulty devices to a range of ailments, including fatal lung cancers. In September, the company reached a $479 million settlement with patients, intended solely for covering the cost of repairing and replacing machines. Separate litigation over illnesses and associated medical costs is currently progressing through the courts.

In an agreement established on Monday with the FDA, Philips commits to meeting a set of standards before potentially resuming sales in the United States. The company also pledges to repair and service devices already in use, as reported by the Times. Philips has affirmed that sales of the devices in other countries will persist.

The company which was formed in 1891 manufactures products like advanced molecular nuclear imaging, computed tomography machines & Solutions, customer services solutions, diagnostic and clinical informatics, diagnostic ECG, digital pathology, emergency care & resuscitation, enterprise Imaging among others.