Urgent Medical Device Recall. Click here for more information.

Urgent Medical Device Recall


 

Dear Patients,

Florida Lung & Sleep Associates has been made aware of the voluntary recall of Philips Respironics machines. On June 14, 2021 Philips issued a recall notification for specific Philips continuous positive airway pressure (CPAP), bi-level positive airway pressure (bi-level PAP), and mechanical ventilator devices.

The recall is in response to potential health risks related to the sound abatement foam component in these devices. Philips reports that it has received a low complaint rate (0.03% in 2020). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.

Statement from Phillips: “We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. We are absolutely committed to supporting the worldwide community of patients who rely on our Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.”

 

Repair and Replacement

Philips indicates that it will replace the current sound abatement foam with a new material and has already begun the preparations. Philips plans to address all affected devices as quickly as possible. Philips is creating a registration process that will allow Patients, Users, or Caregivers to look up their device serial number and begin a claim if the unit is affected. Philips contact Phone number (877) 907-7508. Online functionality will be added within the next few weeks.

Philips Advice for Patients and Customers

Philips advises patients and customers to take the following actions:

  • For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or durable medical equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.
  • For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.

Advice to our Patients

If you are using a Philips CPAP or BIPAP device in the recall list, follow Philips advice above and schedule an appointment online now to discuss the risk, benefits, and alternatives with our Registered Sleep Technologist.

We know it must be a very confusing time, but just know that we will do everything we can to help you navigate through these challenging times. We are working tirelessly with our representatives from Philips Respironics to gather more information about the repair or replacement options. We will update this page as the information becomes available.

 

Read the Philips press release for more information and follow this website for updates directly from Philips.

 

Affected Machines (Full list here)

 

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