FDA Gives 'Most Severe' Class I Label To Philips' Recall Of Faulty Ventilators, Sleep Apnea Machines


The FDA handed down its Class I label, the most severe recall classification, for Koninklijke Philips NV's PHG ventilators for at-home and clinical use after the devices were found to put users at risk of inhaling or swallowing dangerous pieces of debris.

  • Philips initiated the recall in mid-June
  • Patients and healthcare providers using the company's continuous and non-continuous ventilators, including CPAP and BiPAP machines to treat sleep apnea, are asked to stop using the devices immediately and contact Philips to replace the component.
  • Polyester-based polyurethane (PE-PUR) foam built into Philips' ventilators to help reduce sound and vibrations is the root issue.
  • Over time the foam can potentially break down, sending specks of black debris and dangerous chemicals into the air pathway.
  • If inhaled or swallowed, the particles can cause severe irritation of the skin, eyes, and respiratory tract, asthma, and nausea, among other reactions. 
  • They can also potentially damage internal organs like the kidney and liver or have other toxic, carcinogenic effects.
  • According to the recall notice, more than 1,200 complaints have been filed regarding the issue so far.
  • At least 100 injuries are linked to the foam particles.
  • Philips will replace the PE-PUR foam sound abatement component with the new silicone foam sound abatement component in the affected devices to correct in the field.
  • Price Action: PHG shares are up 1.86% at $47.98 during the market session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.
  • Photo via Wikimedia Commons
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