On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions.
On June 30th 2021, the FDA issued a Philips CPAP recall, which also includes BiPAP and Ventilator machines due to potential health risks. Philips advised the FDA of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
Philips reports that the sound dampening foam used inside some of their machines can break down over time, which can cause tiny particles of black foam to enter the device’s air chambers.
Potential safety hazards Philips has reported
- The potential risks of exposure to degraded foam include irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and cancer-causing affects.
- The potential risks of exposure to chemical emissions include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and cancer-causing affects.
Which Machines have been recalled?
| 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) |
If your device is on the list of affected Machines
Should you continue using your machine if it is on the recall list?
According to Philips Respironics:
- 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.*
* This is a recall notification for the US only, and a field safety notice for the rest of the world
If your device is not on the list of affected devices
Continue CPAP as prescribed. The Philips CPAP recall does not apply to you.
How Long Will It Take for Philips Respironics To Address All Recalled Machines?
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.
It will take quite a long time to learn about the potential long-term effects of exposure to this degraded sound insulating foam. If you or a loved one has been exposed to black debris inside a machine that is part of the Philips CPAP recall, call the experienced defective medical device attorneys at Cowan & Hilgeman Law. Call (937) 222-2030 today to schedule your free, no-obligation consultation.
