Philips PAP Recall December 2022 Update

philips recall update

Program update

As we approach the end of 2022, we expect to complete around 90% of the production this year for the delivery of replacement devices to patients. Patients who are still waiting to receive their replacement device can expect to continue hearing from us as we work through some of the more complex challenges of the remediation, including ongoing efforts around:  
  • Helping patients without a Durable Medical Equipment (DME) provider or device connectivity move forward in the remediation process.
  • Connecting with patients’ physicians to obtain their prescription information.
  • Communicating specific actions for patients who use System One and DreamStation Go.

 Update on completed testing for first-generation DreamStation devices

Based on the comprehensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third-party experts and physicians – we now have a complete set of results for the first-generation DreamStation devices. We had already communicated earlier that our visual inspection results to date indicate that the prevalence of visible foam degradation is low, and that test results for volatile organic compound and particulate emissions for both new and used first-generation DreamStation devices are within the applicable safety limits. This latest third-party chemical evaluation and toxicological risk assessment of degraded foam concluded that for the first-generation DreamStation devices, exposure to foam particulates is unlikely to result in an appreciable harm to health in patients.

  • Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions.
  • Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here.
  • Philips Respironics’ guidance for healthcare providers and patients remains unchanged.
  • Philips Respironics will continue with the remediation program.

Please visit here to find more information.

Source: Philips

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