PRODUCT LIABILITY
Philips CPAP and Ventilator Recalls
FAQ's
Which machines are recalled? How do I know if my DreamStation is recalled? The list of recalled products is fairly long and complicated, with details on product numbers and specific time periods.
Philips has recalled the following CPAP, BPAP, and ventilators manufactured between 2009-April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
If your CPAP is included in the recall, first, you’ll want to contact your doctor to see what kind of treatment plan makes sense and if you can still use your CPAP machine. The place where you bought a recalled CPAP machine may be able to help you inquire about a replacement from Philips. Though caution should be taken in light of the FDA’s directive that Philips investigate the VOC release found in at least one instance where this replacement foam was used.
You may also want to talk to your doctor if you’ve been experiencing any of the symptoms or injuries associated with the foam in the recalled CPAP machines described above.
It may be appropriate for you or your physician to report any adverse effects your doctor identifies.
As with all product recalls, the specific length of time it will take to complete the Philips CPAP recall is unclear. Under FDA rules, a product recall is considered done when a company has retrieved and impounded all of the outstanding recalled products that could reasonably be expected to be recovered. Alternatively, when a company has corrected the problems with the product, the recall is over.
If you or someone you know depends on a Philips Bi-Level PAP, CPAP machine, or mechanical ventilator and may have suffered adverse health effects stemming from its use, contact us using the form on this page. We can give you a free case evaluation and discuss your options.
The behemoth Dutch company Philips faces ongoing trouble concerning the health risks associated with its recalled continuous positive airway pressure (CPAP) medical device. People with sleep apnea use CPAP machines to keep oxygen flowing through their nose and mouth to keep airways open when they are sleeping.
On June 14, 2021, Philips recalled numerous CPAP, bi-level positive airway pressure (BPAP), and mechanical ventilator products after health risks from use of the devices surfaced. The U.S. Food and Drug Administration (FDA) found that the foam used to lessen the device’s sound and vibration can result in serious, life-threatening injury and permanent impairment if left untreated. Philips estimates that there are 2 million of these devices used in the U.S. Eighty percent of the Recalled Products are CPAP machines.
Since the initial recall, the FDA has asked the company to do further testing of a silicone foam the company put forth as a “repair and replacement” program for the faulty foam. The replacement silicone foam failed a test for the release of volatile organic compounds (VOCs) at least once. The company also re-upped guidance to physicians and users of the recalled CPAP devices to align with updated FDA guidance that patients should consult their doctors about a treatment plan if they use the CPAP or BPAP recalled devices. More startling news came in December 2021 when Philips expanded the recall to include additional ventilators.
Philips Recalls Devices Posing Serious Health Risks
The majority of the affected devices are in the first-generation DreamStation product family.
The initial CPAP machine recall, along with the Bi-level PAP and ventilators recalls, happened because the polyester-based polyurethane (PE-PUR) foam used to muffle sound in the machines can break down. When the foam degrades, pieces of black foam debris get into the device pathways and can be inhaled or ingested by someone using the machine.
A user may also inhale the chemical gasses released during the foam breakdown. These problems with the sound-abating PE-PUR foam can cause serious harm to the user’s health. The FDA found that the foam issue may get worse in hot and humid conditions and with the use of ozone cleaners or other cleaning methods employed on the devices that Philips had not recommended.
Following the company’s June recall, the FDA categorized the recall as a Class I recall — the most serious type of recall. Philips added specific Trilogy Evo ventilators to the recall in late December 2021 because FDA lab tests in a Philips’ supplier’s manufacturing facilities revealed that the PE-PUR foam was erroneously also used to manufacture the Trilogy Evo ventilators there.
The problems with the PE-PUR foam may result in some serious health problems, including life-threatening medical conditions. Philips admitted in June 2021 that they had received reports of cough, chest pressure, headache, sinus infection, and upper airway irritation from users of the recalled products.
These potential health risks can lead to temporary injuries, symptoms, and complications — including life-threatening injuries that, if not treated, can cause permanent impairment.
The FDA list of potential risks of inhaling or swallowing pieces of foam includes skin, eye, nose, and airway irritation, headache, asthma, and “toxic or cancer-causing effects to organs, such as kidneys and liver.”
The chemical byproducts of the PE-PUR foam breakdown can lead to cancer risks. Inhalation can also cause headache, dizziness, allergic reactions, nausea, and vomiting.
Actual reports of adverse events related to the foam breakdown since April 2021 include cancer, pneumonia, asthma, respiratory problems, infection, headache, cough, breathing difficulties, and chest pain.
If you have experienced cancers of the lung, throat, larynx or esophagus, contact The Lanier Law Firm to discuss your legal options.
Which Philips devices are affected by the recall?
Which machines are recalled? How do I know if my DreamStation is recalled? The list of recalled products is fairly long and complicated, with details on product numbers and specific time periods.
Philips has recalled the following CPAP, BPAP, and ventilators manufactured between 2009-April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
In addition, certain Trilogy Evo ventilators have been recalled.
Key dates for these Trilogy Evo recalled products are:
- April 15, 2021 to May 24, 2021 manufacturing dates
- April 15, 2021 to May 24, 2021 distribution dates
- December 21, 2021 Initiated Recall: 215 Trilogy Evo ventilators; 51 Trilogy Evo repair kits
What Should I do if my CPAP has been recalled?
If your CPAP is included in the recall, first, you’ll want to contact your doctor to see what kind of treatment plan makes sense and if you can still use your CPAP machine. The place where you bought a recalled CPAP machine may be able to help you inquire about a replacement from Philips. Though caution should be taken in light of the FDA’s directive that Philips investigate the VOC release found in at least one instance where this replacement foam was used.
You may also want to talk to your doctor if you’ve been experiencing any of the symptoms or injuries associated with the foam in the recalled CPAP machines described above.
It may be appropriate for you or your physician to report any adverse effects your doctor identifies.
How long will the Philips CPAP recall take?
As with all product recalls, the specific length of time it will take to complete the Philips CPAP recall is unclear. Under FDA rules, a product recall is considered done when a company has retrieved and impounded all of the outstanding recalled products that could reasonably be expected to be recovered. Alternatively, when a company has corrected the problems with the product, the recall is over.
If you or someone you know depends on a Philips Bi-Level PAP, CPAP machine, or mechanical ventilator and may have suffered adverse health effects stemming from its use, contact us using the form on this page. We can give you a free case evaluation and discuss your options.
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