Why Did Philips Respironics Issue a Voluntary CPAP or BIPAP Recall?

Philips Respironics identified a risk that the PE-SUR sound abatement foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.”

What are the Safety Hazards or Health Risks Associated With This Issue & Recall?

As per the Philips Respironics FAQs:
In the event of exposure to degraded foam:
“The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.”
“To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.”

In the event of exposure to chemical emissions:
“The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.”
“To date, Philips has not received reports of patient impact or serious harm as a result of this issue.”

What Are The Philips Respironics Products Impacted?

Many of the Philips Respironics CPAP, APAP, BIPAP and BiPAP machines sold from 2009 onward except the DreamStation 2 used this type of sound abatement foam and are impacted by this recall.

Below is The List of Philips Respironics CPAP Machines Recalled in 2021

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C Series ASV, S/T, AVAPS
OmniLab Advanced Plus In-Lab Titration Device
Non-continuous Ventilator
SystemOne (Q Series)
DreamStation (CPAP, Auto CPAP, BiPAP)
DreamStation Go (CPAP, APAP)
Dorma 400, 500 CPAP
REMstar SE Auto CPAP
Continuous Ventilator
Trilogy 100 Ventilator
Trilogy 200 Ventilator
Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto Ventilator
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40 (not marketed in US)
A-Series BiPAP A30 (not marketed in US)

How Do I Know if My CPAP or BIPAP Is Impacted Under This Recall?

The best way to know if your device is included in the recall is to register your machine for the recall. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number.

To register your device and check if your machine is included in the recall:
Step1: Locate the serial number of your device. The label on the bottom of the unit features a series of letters and numbers that follow the SN or S/N on the label. If you need assistance finding your serial number, you can use this handy guide.

Step2: Go to Philips Respironics recall website.
Complete the registration form. Provide your information such as your name, address, and phone number so Philips Respironics can contact you regarding this recall. Be sure to use your current personal information, regardless of the information you provided at the time of purchase.
Watch for confirmation. Once you’ve completed your registration, if your machine is not included, you will see a message saying your device is not included in the recall. If your machine was included in the recall, you will receive a registration confirmation number as well as important recall updates from Philips Respironics. Please be sure to save the confirmation number provided for your records. Along with your confirmation number, you will receive information about the next steps in the recall process from Philips Respironics. 

Which Philips Respironics Products Are Not Impacted In This Recall?

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include:
DreamStation 2
M-Series
Trilogy Evo
Trilogy Evo OBM
Trilogy EV300
Trilogy 202
BiPAP A40 EFL
BiPAP A40 Pro
Omnilab (original based on Harmony 2)
Dorma 100, Dorma 200, & REMStar SE
All oxygen concentrators, respiratory drug delivery products, airway clearance products.

How Long Will It Take for Philips Respironics To Address All Recalled Machines?

Well, this is not an easy question to answer. The quantum of devices involved in this recall is huge. As per Philips Respironics Chief Executive Frans van Houten said, “We’re going to put all our capacity to focus entirely on replacing and repairing these units,” a process he said would likely take a year. With focusing all capacity on the recall, Houten said that approach “has a consequence that we will not be able to serve new customers, so there’s going to be a shortage in the field.”

Should I Keep Using My Recalled Machine?

There is no great answer to this question. Philips has recommended patients to “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,”. We understand that this recommendation from Philips has not been a satisfactory answer for most of the CPAP users.

Alternatives To Replacing Your Philips Recalled Device?

We understand that replacing your CPAP or BIPAP machine is a expensive affair. One of the main factor in deciding about immediate replacement could be the age of machine. Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. So in case your machine is over 5 years, you may consider following replacement options:
CPAP:
1. Resmed AirSense 10 Autoset Tripack 4G Auto CPAP
2. Loewenstein Prisma Smart Auto CPAP
3. BPL Harmony Auto CPAP
4. Resmed AirStart 10 Auto CPAP With Humidifier
5. Resmed S9 Autoset CPAP
BIPAP:
1. Resmed AirCurve 10 ST BIPAP
2. Resmed AirCurve™ 10 VAuto BIPAP – Tripack
3. Loewenstein Prisma 30ST BIPAP

In case the age of your CPAP or BIPAP is less than 5 years, you may choose a low cost alternate product:
CPAP:
1. BMC RESmart GII Auto CPAP with Humidifier
2. OxyMed Auto CPAP with Humidifier & Mask
3. VentMed DS6 Auto CPAP with Humidifier and Nasal Mask

BIPAP:
1. BMC Y30T BIPAP with Humidifier
2. VentMed DS8 BiPAP ST30 with Humidifier and Full Face Mask
3. Micomme P1 BIPAP with Humidifier
4. Resmed Floton ST 25 – Bipap with Humidifier & Full Face Mask

Final Thoughts:

While the Philips recall is a frustrating experience, it does serve as an opportunity to switch up your CPAP equipment set-up so you can find the device that serves your needs best. If you’re considering purchasing a machine outright, please explore our range of CPAP & BIPAP.

RespBuy.com is readily available to answer your further questions on this recall and can be contacted by writing to sales@respbuy.com or by phone – 88 00 537 507.