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Philips announced that it has started the repairs and replacements of its first-generation respiratory devices that were recalled in the United States. The healthcare unit of the Dutch multinational conglomerate will be addressing the issues in the recalled DreamStation devices numbering to millions.
Based on the recall notice, it was stated that the recalled machines pose potential health risks so customers were immediately told to stop using the affected model units of Philip’s respiratory machines. As Reuters reported, the U.S. Food and Drug Administration (FDA) announced a recall on some models of DreamStation respiratory and ventilator devices in June.
They were found to have become toxic over time as the foam part might deteriorate. When this happens, the machines may potentially cause cancer. Philips received authorization from the FDA to allow rework in the affected units that could reach four million in total.
Almost half of the affected respiratory machines were sold in the U.S. so the latest recall notification is for this country only at this time. For the rest of the world, Philips has issued a field safety notice for the issue which the FDA classified as Class I recall. In any case, the company said that it will take them about a year to replace or repair the machines.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” Royal Philips’ chief executive officer, Frans van Houten, said in a press release. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients.”
The CEO is also urging patients who are using the affected devices to register their units on the website dedicated for the recalls. This will help them with the process of tracking and obtaining details about the machines.
Aside from the ongoing repairs and replacements, Philips continues to communicate with the FDA to address any other details of the recall as well as mitigation plans in the country. The company has reserved $590 million for the recall operation this year.
