Philips Respironics Product Recall: Important Information for Careica Clients

Wednesday, June 16, 2021


NOTICE:
Careica Health is in close contact with Philips Respironics to stay up-to-date on the issue. We will continue to update this blog post with new information as it becomes available.

Philips Respironics is voluntarily recalling a number of medical devices including Dreamstation and System One CPAPs. For your immediate reference Philips Respironics makes the following statement regarding foam degradation exposure:

Potential Hazard: Philips has determined from user reports and lab testing that under certain circumstances the foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user of its Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) and Mechanical Ventilator devices. The foam degradation may be exacerbated by environmental conditions of higher temperatures and humidity in certain regions. Unauthorized cleaning methods such as ozone may accelerate potential degradation." 

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More information regarding this recall

Communication from Philips Respironics, including a comprehensive list of recalled devices:

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Philips Respironics portal to register your recalled device:

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Medical guidance regarding this recall

For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states:

  • For patients using affected CPAP or Bi-Level devices at night for obstructive sleep apnea, we would advise contacting their physician in a timely fashion to decide on the best course of action and continuing using their device in the meantime.
  • For patients who develop symptoms compatible with irritation from foam degradation particles such as cough, headaches, sinus infections that started after starting on PAP treatment OR who notice particles in their humidifier chamber, tubing or mask; they should contact their physician as soon as possible to discuss options and they should be considered a priority for clinical decision-making.

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Have a question regarding this recall? Give us a call.

If you need any further information or support concerning this recall, please contact Careica Health at 1-888-297-7889.