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On June 14, Philips issued a voluntary recall for particular Philips Respironics units. These embody CPAP and BPAP units to deal with obstructive sleep apnea. Listed here are solutions to some steadily requested questions in regards to the recall.
The place can I discover details about the recall?
The recall notification is posted at philips.com/src-update. Additionally, the FDA has posted responses to a number of questions in regards to the recall. Learn FAQs from the FDA.
How do I discover out if my PAP machine has been recalled?
You can begin by viewing a listing of recalled units on the Philips web site. To verify that your machine has been recalled, you’ll want to go to the Philips registration website to register your machine. The web site offers you directions on how one can find the serial variety of your machine. It additionally will information you thru the registration course of. You possibly can contact Philips at [email protected] or (877) 907-7508 for added assist.
View a video on how one can register your machine:
Will Philips substitute my PAP machine?
Philips has acknowledged that it’s going to restore or substitute recalled units. Philips is changing some units with new DreamStation 2 machines. These units have a unique, silicone-based foam that’s not included within the recall. Philips additionally plans to restore some recalled units by altering the froth. Philips acknowledged in September 2021 that the corporate intends to finish the restore and substitute packages inside roughly 12 months.
If my machine has been recalled, ought to I cease utilizing it?
An FDA security communication advises you to speak to your well being care supplier to determine on an acceptable remedy on your situation. Your medical supplier might help you establish in case you ought to proceed or discontinue remedy. Your supplier might prescribe a brand new PAP machine for you. Your supplier additionally might focus on different remedy choices with you.
Why had been the units recalled?
Philips signifies that there have been reviews of black particles being discovered within the tubing, masks, and across the connections to the machine. These particles are from foam contained in the machine that’s used to maintain it quieter. The priority is that these particles could also be inhaled when the machine is getting used. This might end in issues reminiscent of complications, bronchial asthma, and nausea. Testing by Philips additionally has discovered that there are VOCs (unstable natural compounds) which might be being launched into the airflow from the CPAP machine foam. These should not but recognized to have induced medical points, however the FDA is anxious about what this will likely trigger sooner or later. Since this can be a new concern, Philips is gathering information to raised perceive the potential danger of this foam.
The FDA notes that between 2014 and April 2021, Philips submitted 30 medical machine reviews (eight from the U.S.) they recognized as associated to foam breakdown. Previous to April 2021, the FDA didn’t obtain any medical machine reviews of affected person harm or hurt associated to foam breakdown. Since April 2021, the FDA has acquired greater than 3,000 medical machine reviews associated to foam breakdown.
What does this need to do with ozone cleaners? How ought to I clear my PAP machine?
Philips reviews that the froth used to maintain the units quieter breaks down faster when uncovered to excessive warmth, excessive humidity, and non-approved cleansing units that use ozone. The FDA recommends that you simply observe the cleansing directions supplied by the PAP producer. These instructions usually embody common cleansing of your masks, cushions, tubing and water chamber with cleaning soap and water. PAP producers additionally advocate altering your PAP filter frequently. An FDA security communication warned that you need to keep away from cleansing your PAP machine or equipment (reminiscent of masks, tubing, headgear) with any machine that makes use of ozone gasoline or UV mild. In response to the FDA, it’s unknown if these cleaners are protected and efficient. See the FDA shopper replace for extra particulars. Moreover, Philips launched cleansing and inspection directions for present equipment.
Up to date Nov. 19, 2021
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