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Phillips Respironics Recall Information

For patients who have received a new device:

If you have received a replacement machine for your recalled Respironics device, instructions were included with the new machine. If you have questions or need further assistance, Respironics has developed a page with step-by-step instructions on how to set up your new device.

DreamStation 2

If you have received a DreamStation 2 as a replacement for your previous CPAP machine, please visit the webpage below to find instructions and next steps for setting up your new device and returning your old one: DreamStation 2 Set-Up and Replacement Page

DreamStation 1

If you have received a DreamStation 1 (DreamStation original) as a replacement for your previous CPAP machine, please visit the webpage below to find instructions and next steps for setting up your new device and returning your old one: DreamStation Set-Up and Replacement Page

Patients who have received their replacement device and are in need of Customer Support should call: 833-262-1871. *This number is ONLY for patients who have received a replacement machine.

 

For Patients with Unregistered Devices:

CarePro Home Medical has been made aware of the voluntary recall of Philips RespironicsPhilips Respironics Logo CPAP and Bi-Level PAP machines.

Philips Respironics has determined these steps should be taken immediately by current CPAP and Bi-Level PAP users:

1. Discontinue use of your device and work with your physician to determine the most appropriate options for continued treatment.

2. Register your device:

  • Online via this link: https://www.philipssrcupdate.expertinquiry.com/ 
    • Philips has established a registration process that allows Patients, Users, or Caregivers​ to look up their device serial number and begin a claim if their unit is affected.
  • Or by calling 1-877-907-7508.

As of September 1st, 2021, Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US.

For the latest from the FDA (Food and Drug Administration) on this recall, please visit this link to view their current FAQs to help assist those affected: FDA - Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

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