Philips Respironics Recall - All You Need To Know

On 14th June 2021, Philips Respironics voluntarily issued a notification for recalling certain models of mechanical ventilators, Continuous Positive Airway Pressure (CPAP), and Bi-Level Positive Airway Pressure (BiLevel PAP or BiPAP) devices within the United States. This was accompanied by the issuance of a field safety notice for countries outside of the US.

The recall comes in response to the discovery of potential health risks caused by the breakdown of polyester-based polyurethane (PE-PUR) foam used in these devices. The foam, used for reducing sound and vibrations in the said devices, can break down into tiny particles, which could be swallowed or inhaled by the individual using the machines.

Earlier in April, the company had put forward an update regarding the identification of potential issues arising from the use of the sound abatement foam in some specific products. The official notification issued by the company seeks to inform all their customers about the negative impact of degraded sound abatement foam along with advising them on the steps to take.

The Possible Risks

The recall notification for the US and the international field safety notice intends to inform customers of the risks of using these affected devices. The health issues may be caused either by exposure to degraded sound abatement foam or from chemical emissions.

Exposure to foam degradation, which may result from unauthorized cleaning methods, high heat, or high humidity, can lead to skin, eyes, and respiratory tract irritation, inflammation, asthma, and so on. In addition, it can adversely affect organs like the liver and kidneys and may also have carcinogenic effects.

Patients exposed to chemical emissions are at the risk of experiencing dizziness, headaches, nausea, hypersensitivity, etc. Skin, eye, nose and respiratory tract irritations may also occur.

To date, Phillips has received several complaints and reports about the presence of black foam particles within the airpath circuits of selective device models. People have also reported issues such as cough, headaches, chest pressure, sinus infection, and upper airway irritation arising from exposure to the degraded foam particles. The company hasn't received any reports regarding any severe impact from exposure to chemical emissions as of yet. However, they are constantly monitoring the situation in the US and international markets to ensure patient safety.

How To Know If Your Device Is Affected?

The company has provided the necessary information in the notification to help customers identify the affected products. Here is a list of the specific devices that have been recalled:

●E30

●DreamStation ASV

●DreamStation ST, AVAPS

●SystemOne ASV4

●C Series S/T, AVAPS

●OmniLab Advanced Plus

●System One 50 series

●System One 60 series

●DreamStation CPAP, Auto CPAP, BiPAP

●DreamStation GO CPAP, APAP, Auto CPAP

●Dorma 400, 500 CPAP, Auto CPAP

●Trilogy 100 Ventilator

●Trilogy 200 Ventilator

●Garbin Plus, Aeris, LifeVent Ventilator

●A-Series BiPAP Hybrid A30

●A-Series BiPAP V30 Auto Ventilator

●A-Series BiPAP A40

●A-Series BiPAP A30

All devices of the above models manufactured before 26th April 2021 have been recalled by the company, irrespective of their serial numbers.

The company has also put forward a list of the machines and devices not affected by this issue. These may have been designed with new sound abatement materials and technologies that do not encounter this particular issue, or the foam is placed in a different location altogether. According to the official website of the company, in addition to all oxygen concentrators, respiratory drug delivery products, and airway clearance products, the list of unaffected devices includes the following models:

●Trilogy Evo

●Trilogy Evo OBM

●Trilogy EV300

●Trilogy 202

●A-Series Pro and EFL

●M-Series

●DreamStation 2

●Omnilab (original based on Harmony 2)

●Dorma 100

●Dorma 200

●REMStar SE

●V60 Ventilator

●V60 Plus Ventilator

●V680 Ventilator

What You Need To Do

Philips has put forward the necessary guideline that customers and patients using such devices need to follow. These can be summarized as follows.

Consult A Physician

The recall notification and field safety notice advises patients to get in touch with physicians to assess the potential risks and benefits. In addition, for patients using the CPAP and BiLevel PAP devices, the company recommends discontinuing the use of the affected devices and determining the further course of action with their physician.

On the other hand, patients using mechanical ventilators for sustaining life are advised not to discontinue the use unless the physician suggests an appropriate treatment plan.

Register Your Device

Customers using any of the affected models need to register their devices by visiting the official website. Post registration, they can check the replacement status by visiting the portal. The registered customers will receive a replacement designed with a different foam material. Philips may also repair customer devices to replace the sound abatement foam. Users need to return the affected device after receiving the replacement.

Cleaning And Maintenance Recommendations

The company has put forward some recommendations to reduce the risk potential of using such devices. First, customers should avoid using ozone-related cleaning products as it hastens the degradation process. Instead, they are advised to stick to the approved cleaning methods mentioned in the device's usage instructions.

In addition, the risks are greater for older devices. Therefore, customers are advised to review the age of the products, especially the BiLevel PAP and CPAP devices, without further ado. Philips recommends replacing any such devices that have been in use for five years or more.

Ongoing Efforts By The Company

As of now, the company has taken steps to address this issue in the best way possible. They have a comprehensive plan in place to replace the current sound abatement foam with an alternative material that is free from such safety hazards. Around 3,000,000 repair kits and replacements have been manufactured globally to date, and the company has shipped 1,400,000 devices in the US till July 2022.

Philips aims to wrap up the repair and replacement program for most of the patients who have registered their devices by December 2022. The latest updates can be found by visiting the company's official website.