After Tests, Recalled DreamStation Sleep Devices Unlikely To Cause Harm, Philips Says

After Tests, Recalled DreamStation Sleep Devices Unlikely To Cause Harm, Philips Says
  • Koninklijke Philips NV PHG has updated the comprehensive test and research program following the voluntary recall notification/field safety notice to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP, and mechanical ventilator devices.
  • The company says additional test results and assessments have now been completed for the first-generation DreamStation devices.
  • Related: Philips Flags Two Additional Issues With Reworked, Placed Ventilators.
  • Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was "unlikely to result in an appreciable harm to health in patients," provided the machines had not been treated with ozone-based cleansing products.
  • The company said results also showed that exposure to volatile organic compound emissions was not expected to have long-term health consequences for patients.
  • Philips said further tests showed machines cleaned with ozone products were 14 times more likely to have significant visible foam degradation than those treated with authorized products.
  • The FDA is still considering the data and analyses and "may reach different conclusions," Philips said.
  • The test and research program has been conducted with five independent, certified testing laboratories. The results have been reviewed and assessed by third-party qualified experts, Philips Respironics, and an external medical panel.
  • Price Action: PHG shares are up 5.91% at $13.97 during the premarket session on the last check Wednesday.

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