On June 14, Philips issued a voluntary recall for particular Philips Respironics gadgets. These embody CPAP and BPAP gadgets to deal with obstructive sleep apnea. Listed below are solutions to some often 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 gadgets on the Philips web site. To substantiate that your gadget has been recalled, you could go to the Philips registration website to register your gadget. The web site offers you directions on how one can find the serial variety of your gadget. It additionally will information you thru the registration course of. You may contact Philips at [email protected] or (877) 907-7508 for added assist.
View a video on how one can register your gadget:
Will Philips change my PAP gadget?
Philips has said that it’s going to restore or change recalled gadgets. Philips is changing some gadgets with new DreamStation 2 machines. These gadgets have a unique, silicone-based foam that isn’t included within the recall. Philips additionally plans to restore some recalled gadgets by altering the froth. Philips said in September 2021 that the corporate intends to finish the restore and substitute packages inside roughly 12 months.
If my gadget has been recalled, ought to I cease utilizing it?
An FDA security communication advises you to speak to your well being care supplier to resolve on an acceptable therapy to your situation. Your medical supplier might help you establish when you ought to proceed or discontinue therapy. Your supplier might prescribe a brand new PAP gadget for you. Your supplier additionally might focus on different therapy choices with you.
Why had been the gadgets recalled?
Philips signifies that there have been reviews of black particles being discovered within the tubing, masks, and across the connections to the gadget. 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 gadget is getting used. This might end in issues resembling complications, bronchial asthma, and nausea. Testing by Philips additionally has discovered that there are VOCs (unstable natural compounds) which are being launched into the airflow from the CPAP gadget foam. These usually are not but identified to have brought about medical points, however the FDA is worried about what this will trigger sooner or later. Since it is a new concern, Philips is amassing information to raised perceive the potential danger of this foam.
The FDA notes that between 2014 and April 2021, Philips submitted 30 medical gadget reviews (eight from the U.S.) they recognized as associated to foam breakdown. Previous to April 2021, the FDA didn’t obtain any medical gadget reviews of affected person damage or hurt associated to foam breakdown. Since April 2021, the FDA has obtained greater than 3,000 medical gadget reviews associated to foam breakdown.
What does this need to do with ozone cleaners? How ought to I clear my PAP gadget?
Philips reviews that the froth used to maintain the gadgets quieter breaks down faster when uncovered to excessive warmth, excessive humidity, and non-approved cleansing gadgets that use ozone. The FDA recommends that you just comply with the cleansing directions offered 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 suggest altering your PAP filter frequently. An FDA security communication warned that you must keep away from cleansing your PAP machine or equipment (resembling masks, tubing, headgear) with any gadget that makes use of ozone gasoline or UV gentle. In line with the FDA, it’s unknown if these cleaners are secure and efficient. See the FDA shopper replace for extra particulars. Moreover, Philips launched cleansing and inspection directions for current equipment.
Up to date Nov. 19, 2021
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