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Philips Recall Notice

Sleep Technologies is aware that Philips Respironics issued a voluntary recall notice on June 14th of its sleep apnea and ventilator machines because of potential health risks.

For those using a Philips Respironics device, the company advises them to do the following:

  • For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians or your durable medical equipment (DME) provider to determine the benefits and potential risks of continuing therapy.
  • For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy without consulting physicians to determine appropriate next steps.
  • NOTE: If you currently use the DreamStation series 2 device (the newest model), this model is not affected by the recall.

Philips also recommends that patients using a Philips Respironics ventilator stop using ozone-related cleaning products and adhere to their device’s “Instructions for Use” for approved cleaning methods.

Additionally, Philips reminds those using a Philips Respironics ventilator to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after 5 years of use.

For more information about the recall and to determine if your device is affected, you can visit the Philips sleep and respiratory care update page

If you have any questions, please contact your physician or your DME provider.

If you develop a serious medical condition, please dial 911 or visit your nearest emergency department.

FAQ:

Why did Philips Respironics announce a voluntary recall on continuous and non-continuous ventilators? Philips said it has recalled some breathing devices and ventilators because of foam materials in its devices used for sound abatement that might degrade and become toxic, potentially causing cancer. When the foam degrades, it could be ingested or inhaled by the user. The foam materials could also off-gas certain chemicals, especially when cleaned using unapproved methods such as ozone.

Which Philips Respironics devices are included in the voluntary recall? A list of devices included in the recall — with names and photos — is available on the Philips sleep and respiratory care update page

What is Phillips going to do about this? Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices will be either replaced with a new or refurbished unit that incorporates the new material or repaired to replace the sound abatement foam. The new material will also be used in future products.