FDA Recalls Numerous Philips Respironics Sleep Apnea Machines

Philips, the world’s largest manufacturer of devices used to treat sleep apnea, announced on June 14, 2021 a Class I (most serious) recall of 3 to 4 million continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP), and mechanical ventilator devices for safety issues related to the polyester-based polyurethane (PE-PUR) foam used to dampen sound in these devices.

The PE-PUR foam may degrade into particles and enter the device’s air pathway to be ingested or inhaled by the user. Degradation may occur with the use of certain cleaning products and environmental conditions involving high humidity and temperature. Alternatively, the PE-PUR foam may off-gas certain chemicals during initial operation and, possibly, throughout the device’s useful life.

The following CPAP and BiPAP models manufactured before April 26, 2021 are subject to the recall:

  • E30 (Emergency Use Authorization)
  • DreamStation ASV (Also known as DreamStation BiPAP autoSV)
  • DreamStation ST, AVAPS (Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T)
  • SystemOne ASV4 (Also known as SystemOne BiPAP autoSV, System One BiPAP autoSV Advanced)
  • C Series S/T, AVAPS (Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series))
  • OmniLab Advanced Plus (In-Lab Titration Device)
  • System One 50 series (CPAPs, Auto CPAP, BiPAPs)
  • System One 60 series (CPAPs, Auto CPAP, BiPAPs)
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation GO CPAP, APAP, Auto CPAP
  • Dorma 400, 500 CPAP, Auto CPAP (not marketed in US)

Potential Health Risks & Safety Hazards

According to Philips, the potential risks of exposure to degraded foam include:

  • Irritation (skin, eye, and respiratory tract)
  • Inflammatory response
  • Headache
  • Asthma
  • Adverse effects to other organs (e.g. kidneys and liver)
  • Toxic carcinogenic affects

At the time of the issuance of the June 14, 2021 recall/field safety notice, Philips Respironics had received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips had also received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection.

Philips further reported that the potential risks of exposure to chemical emissions from affected foam include:

  • Headache/dizziness
  • Irritation (eyes, nose, respiratory tract, skin)
  • Hypersensitivity
  • Nausea/vomiting
  • Toxic and carcinogenic effects

At the time of the issuance of the June 14, 2021 recall/field safety notice, Philips had not received reports of patient impact or serious harm as a result of this issue.

What to Do if Your Philips Machine Is Under Recall

Consumers who use these recalled sleep apnea machines are advised to consult their physicians, immediately. Philips is currently working on a program to repair or replace defective devices as part of the recall.

Complications include:

  • Headache
  • Irritation
  • Inflammation
  • Chronic bronchitis
  • Sudden respiratory distress and failure
  • Kidney damage/failure/disease
  • Liver damage/failure/disease
  • Heart failure
  • Heart attack
  • Stroke
  • Leukemia
  • Non-Hodgkin’s lymphoma
  • Multiple myeloma
  • Breast cancer
  • Lymphatic cancer
  • Nasal cancer
  • Brain cancer
  • Prostate cancer
  • Bladder cancer
  • Testicular cancer
  • Stomach cancer
  • Hematopoietic cancer
  • Rectal cancer
  • Papillary carcinoma
  • Thyroid cancer

For updates from Philips, visit its Medical Device Recall Notification page. Updates from the FDA can be found here.

Injured by a Philips Sleep Apnea Machine? You Have Rights!

If you or a loved one has used one of the affected products and suffered one or more of these complications, you may be entitled to compensation for medical expenses and other damages. Please call (916) 520-6639 for a free consultation with the Sacramento medical device attorneys at Kershaw Talley Barlow.

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