Attorney General Tong Urges FDA to Expedite Philips CPAP Replacement
HARTFORD, CT – A report on ct.gov states that Attorney General William Tong asked the U.S. Food and Drug Administration to increase the agency’s handling of the Philips Respironics recall and repair process. Attorney General Tong stated that he wants to make certain that the millions of affected patients are able to resume the use of their CPAP, ventilator, and BiPAP devices as quickly as possible.
On June 14, 2021, Philips Respironics announced a voluntary recall of its E-30, Dreams Station S.T., Dream Station ASV, C-Series ASV, C-Series S/T, AVAPS, System One ASV4, AVAPS, System One (Q Series), Omnilab Advanced+, Dream Station Go, Dream Station, Dorma 400, Dorma 500, Trilogy 100, REMStar SE Auto, A-Series BiPAP Hybrid A30, Trilogy 200, A-Series BiPAP V30 Auto, A-Series BiPAP A30, and A-Series BiPAP A40, due to potentially life-threatening problems linked to the degradation of the unit’s “polyester-based polyurethane (PE-PUR) sound abatement foam.” Specifically, as the PE-PUR foam degrades, it releases particulates into the breathing machines’ air pathways and releases some toxic gases. These chemicals are “potentially carcinogenic” and present a grave risk to patients. To initiate a recall or repair, customers must register their affected machines on the Philips website.
The report states that the notice issued by Philips Respironics to its patients never told customers how the company would replace or repair the recalled breathing devices. Moreover, purchasers have reported that phone calls to Philips’ toll-free phone number provided in the recall notice “do not connect callers with people knowledgeable about the recall.” In addition, customer requests for return telephone calls are not being completed by Philips.
Attorney General William Tong has demanded Philips provide its customers with reimbursement, replacement machines, and repair guidance. However, this recall is being regulated by the U.S. FDA. Spokespeople for Philips stated that the FDA had accepted a corrective action plan, but Philips and the FDA have not released the plan publicly, causing concern and confusion. The Attorney General believes that greater transparency is needed to assure public confidence in the corrective action plan.
Attorney General Tong said in his letter to the FDA that millions of customers who rely on the breathing machines are upset and scared due to their lack of understanding of what they need to do. The Attorney General also stated that the FDA approved the corrective action plan but has not been made public.
Customers who use a Philips Respironics device should register their product on Philips.com to receive guidance and updates on the recall.
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