URGENT:  Medical Device Recall Notice

Philips Respironics

CPAP and B--Level PAP Devices

The Philips Recall Notification

Those patients wishing to schedule a discussion regarding this matter can

Complete the contact form below to discuss options for care alternatives during this recall.

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 As a Philips and ResMed provider, this page will be kept updated as information becomes more available.

PHILIPS MEDICAL DEVICE RECALL

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of their Sleep & Respiratory Care portfolio.

At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

Philips 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.

At this time, this process is only available for Patients, Users, or Caregivers in the USA and Canada. More countries will be added shortly.

For more information on this Field Safety Notification*, please visit

Philips.com/SRC-Update.

Helping Patients Help Themselves

Provide Us Your Information If You Wish To Be Contacted Regarding This Recall

Recall (Click Below To Access The Philips Recall Letter)

Philips PAP Recall Notification

 

Most patients are unaware that on June 14, Philips Respironics issued a recall notification for an estimated 3-4 million bi-level PAP, CPAP and mechanical ventilator devices in response to potential health risks related to the sound abatement foam component in these devices. Philips is advising patients using affected BiLevel PAP and CPAP devices to discontinue use of their device and work with their provider to determine the most appropriate options for continued treatment. We are positioned to help you during this recall.

 

As a direct customer of Philips and ResMed and as an occasional distributer of PAP devices I received the URGENT Medical Device Recall Notice for distributors, institutions and device customers (patients). Also, as a DME provider of oral appliance therapy for OSA and having worked with physicians across the state I certainly have seen both forms of therapy and the advantages and disadvantages of each. Clearly with PAP we have efficacy but chase compliance while with Mandibular Advancement Devices we have compliance but chase efficacy. It goes without being said that no one form of therapy treats all segments of the population.  The AADSM issued the following statement:

 

“Sleep apnea significantly impacts daytime sleepiness and quality of life, and many patients rely on CPAP as their form of therapy” “To ensure they continue to have treatment during this recall, those suffering from obstructive sleep apnea should know that Oral Appliance Therapy is a proven, effective treatment option.”  First let us categorize and prioritize the population this recall effects.                   

The following three groups exist:

 

Those wearing PAP all night

Those wearing PAP part of the night

Those that are PAP intolerant

 

Argument can be made that although 1/3 of patients are fully treated, 1/3 are sub-optimally treated (because PAP Compliance is considered to be only 4hrs/night 7 of 10 nights) and 1/3 are left untreated. Our medical system leaves all three groups largely unsupervised while the evidence suggests these three groups demand different considerations.


      The Research Supports The Above

About The Philips Recall

Philips recall notification

About Oral Appliance Therapy

OAT Fact Sheet

OAT Evidence Brief

Request A Call Back

To the right are two PAP devices that could be considered to inexpensively substitute for the recalled Philips products until they can be replaced after which these could then be used as a backup or for travel .....


Regards,

 

Dr. John L. Bouzis


email: jbouzis@aol.com

voice: 307-265-3595


Updates

Updates Will Be Posted Below

Green Icons Contain Updated Links With Date & Descriptions

AHRQ
An Entirely Different Kind Of Problem
Added 07/14/2021

AHRQ 155 Pages Key Points
Marked For Quick Review
Added 07/14/2021

    Philips Sleep & Respiratory Care
 Update - Clinical Information July8th
                            Added 07/19/2021

Updates When Made Available

Updates When Made Available

Updates When Made Available

Updates When Made Available

Updates When Made Available

Updates When Made Available

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