The recall and repair operations affect those in the United States more than other countries. The company, domiciled in The Netherlands, will start repairing first-generation Phillips DreamStation devices sold in the United States. Thursday, SeptemBeginning this month, September 2021, Dutch company Royal Phillips (RP), the makers of the defective Phillips brand of CPAP sleep apnea devices and ventilators, will start implementing a solution to the life-threatening problems the machines have created. Users of the Phillips DreamStation could face a medical nightmare and should see a lung cancer specialist immediately Those measures include the release of the affected machines’ updated instructions for use, as well as the launch of a repair and replacement program, complete with a newly established claims processing center focused solely on ventilator-related concerns, van Houten explained.Tell us what happened: Send The Phillips Sleep Apnea Machine Recall And Replace Affects Mostly US Owners “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Philips CEO Frans van Houten said in the company’s original June 14 recall notice. Jude Medical, Alere pay combined $65M to settle DOJ claims they knowingly sold defective devices The agency also noted that, because of a lack of similar ventilators from other device makers, patients and healthcare providers may decide to continue using Philips’ ventilators after weighing the health benefits against the risks, albeit with the addition of an inline bacterial filter. Potential alternatives to the CPAP and BiPAP machines include using a different device, seeking out a completely different form of treatment, such as positional therapy and oral appliances, or making long-term health changes to combat the root causes of sleep apnea, which can range from obesity, drinking and smoking to genetic factors and chronic medical conditions like congestive heart failure, asthma and more.
In addition to stopping use of the devices and allowing Philips to replace the polyurethane foam with a silicone alternative, the FDA suggested that patients requiring respiratory support seek out an alternative treatment. The recall affects nearly two dozen models of Philips’ ventilators with product codes BZD and MNS that were manufactured between 2007 and April of this year and distributed beginning in July 2009. RELATED: FDA authorizes CPAP machines and more as emergency ventilator alternativesĪccording to the recall notice, so far, more than 1,200 complaints have been filed regarding the issue, with at least 100 injuries linked to the foam particles. They can also potentially damage internal organs like the kidney and liver, or have other toxic carcinogenic effects. If inhaled or swallowed, the particles can cause serious irritation of the skin, eyes and respiratory tract, as well as asthma and nausea, among other reactions.