Attorney General Tong Seeks Information Regarding Philips Respironics CPAP Machine Recall(Hartford, CT) – Prompted by complaints from multiple Connecticut patients and medical providers, Attorney General William Tong today sent a letter to Philips Respironics seeking information regarding a recall of certain BiPAP, CPAP and ventilator devices.
Philips Respironics issued a voluntary recall on June 14, 2021 of its E-30, Dream Station ASV, Dreams Station ST, AVAPS, , System One ASV4, C-Series ASV, C-Series S/T, AVAPS, Omnilab Advanced +, System One (Q Series), Dream Station, Dream Station Go, Dorma 400, Dorma 500, REMStar SE Auto, Trilogy 100, Trilogy 200, A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40, and A-Series BiPAP A30, noting potentially life-threatening issues related to degradation of polyester-based polyurethane (PE-PUR) sound abatement foam. Particulates released from degrading PE-PUR foam into devices’ air pathways and off-gassing of chemicals are toxic and potentially carcinogenic, presenting a serious and unacceptable risk to patients.
Unfortunately, the notification sent by Philips Respironics to patients fails to explain how the company will repair or replace the defective devices. Patients have reported that calls to the toll-free phone number provided do not connect callers with people knowledgeable about the recall, and requests for return phone calls are not fulfilled.
Attorney General Tong’s letter requests that Philips Respironics explain whether all defective devices will be replaced at no charge, when those devices will be replaced, and whether the company has notified medical equipment suppliers about the need to stop distributing the defective devices. The letter requests a response within 10 days.
“My Office is receiving a growing number of complaints from patients and medical providers concerning a voluntary recall by Philips Respironics of certain ventilator devices that have a defect which your company and the Food and Drug Administration have determined is potentially life-threatening,” the letter states. “Patients are justifiably alarmed that the defect and lack of an immediate replacement have thwarted their use of a life-sustaining device.”
Assistant Attorney General Thomas Ryan and Deputy Associate Attorney General Jeremy Pearlman, Chief of the Antitrust and Government Program Fraud Section assisted the Attorney General in this matter.