Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

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News and Updates > Replacement Trilogy Circuit Inspection and Cleaning Instructions

Replacement Trilogy Circuit Inspection and Cleaning Instructions

June 1, 2022

After receiving a remediated Trilogy 100/200 device:

 

Periodically inspect the tubing and accessories, including the mask, for any damage or signs of wear according to their instructions for use. If any of the following accessories that come in contact with the air pathway are being re-used from an affected device, visually inspect for evidence of black foam particles or other particulate contamination before starting or resuming therapy on the replacement machine:

 

  • Tubing (including tracheotomy tubing and exhalation valves, if used)
  • Mask components (mask, cushions, and integrated tubing, if used)
  • Humidifier airflow path, including tank, water chamber, and seals (if used)

 

If there is no evidence of black foam particles or other particulate contamination on any of these components

 

  • Clean each component and allow to dry. Note: Cleaning instructions for ventilator accessories, including methods and detergents that are approved, vary from accessory to accessory and are established by their manufacturer. Please reference the instructions for use that were provided for detailed instruction on how to clean.
  • If single use/disposable accessories, such as bacteria filters, HMEs, or disposable circuits, were used on an affected device, please dispose and replace.
  • Reassemble and resume therapy on the replacement devices.
  • If visible black foam particles or other particulate contamination are observed on any of these components: Remove these components from use and replace with new components prior to restarting therapy.

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