Recall of Philips manufacturer’s CPAP devices

Announced on June 14, manufacturer Philips Respironics issued a voluntary recall of continuous and non-continuous ventilators (certain CPAP devices, dual-stage PAP and ventilators) due to two issues with polyurethane soundproofing foam polyester-based (PE-PUR) used in these devices: 1) PE-PUR foam can break down into particles that can enter the air circuit of the device and be ingested or inhaled by the user, and 2) PE-PUR foam can give off gases of certain chemicals.

Out of caution and based on the information available, Philips has raised the potential health risks associated with the noise-canceling foam used in certain Philips Continuous Positive Airway (CPAP), Two-Stage Positive Airway, and mechanical fans.

“Potential health risks include exposure to degraded soundproofing foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam. “

Although Groupe Medicus is not responsible for the recall, everything is done to support you. The situation is monitored very closely on a daily basis and each of us, especially your respiratory therapists, are fully committed to maintaining constant communication with you. Please see the Philips website for details.

ELEMENTS TO REMEMBER

  • This recall involves Philips C-Series devices and all DreamStation platforms manufactured between November 2009 and April 26, 2021.
  • The use of these models would present possible health risks
  • The manufacturer plans to put in place a plan to replace or repair the devices affected by this preventive recall.

What devices are affected by the recall notification?

The recall issued by Philips involves Philips two-level positive pressure (two-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices manufactured between November 2009 and April 2021.

Two-tier CPAP and PAP devices

Continuous ventilator, ventilatory assistance minimal, institutional use

E30 (autorisation d’utilisation en urgence)
Continuous ventilator, without breathing assistance DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T et AVAPS
OmniLab Advanced+
Non-continuous fan SystemOne (Série Q)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto

Mechanical fans

Continuous fans

Trilogy 100
Trilogy 200
Garbin Plus, Aeris, LifeVent

Continuous ventilator, ventilatory assistance minimal, institutional use

A-Series BiPAP Hybrid A30 (non vendu aux É-U)
A-Series BiPAP V30 Auto
Continuous ventilator, without breathing assistance A-Series BiPAP A40
(non vendu aux É-U)
A-Series BiPAP A30
(non vendu aux É-U)

Please see the Philips website for details. To help you determine if your device is affected by the recall, find your device’s serial number and use the Philips Online Device Identification Tool.

What are Philips recommendations?

  • For patients using two-tier PAP and CPAP devices: Philips recommends that you stop using your recalled device and consult your treating physician or pulmonologist as soon as possible to identify alternatives for continuing your treatment.
  • For patients using life-sustaining mechanical ventilation devices: DO NOT interrupt or modify prescribed therapy without consulting a physician or pulmonologist to determine the appropriate next steps.

Will the recalled devices be replaced?

At this time, we are unable to say what will happen to your device, whether it will be replaced or repaired. According to information provided by Philips, the manufacturer intends to put in place a plan to replace or repair the recalled devices. The manufacturer is to plan and organize this plan. At this time, we can’t tell you what will happen to your device. Please see the Philips website for details.

When will I receive my new device?

This information is unknown to us at this time. Please see the Philips website for details.

Should I contact my insurance company?

To ensure optimal functioning of your device, it is recommended to change it after 5 years. We advise you to call your insurance to check if your coverage allows you to get a new CPAP machine.

“In addition, Philips reminds its customers and patients to verify the age of their PAP and CPAP devices at two levels, as it is generally recommended that they be replaced after five years of use. “

TO ALL OUR PATIENTS.

Rest assured that our team is in constant communication with Philips and is working in collaboration with various stakeholders in the field to put in place a clear action plan and a procedure for your support. This will be communicated to you as soon as possible.

Thank you for your usual collaboration!