AMSTERDAM, NETHERLANDS (WTEN0) – Philips Respironics has issued a recall on thousands of ventilators and CPAP machines. The recall only affects units sold in the United States.
The units affected include specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilators. The issue stems from potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
Philips says the foam has a chance to break down and be inhaled by device users, and the foam may off-gas certain chemicals. They say the deterioration could intensify by using unapproved cleaning methods, or by using in high-heat and high-humidity environments.
The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.
Philips has received some complaints of possible patient impact due to foam degradation. There have not been any reports of death or patient impact related to chemical emissions.
Customers and patients should take the following action:
- 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.
Recall List:
All Devices manufactured before April 26, 2021
Continuous Ventilator
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
- A-Series BiPAP A40
- A-Series BiPAP A30
Actions to take if you use the above 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.
- If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.
- Register your device(s) on the recall website www.philips.com/src-update
- The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two issues.
- The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
- Call 1-877-907-7508 if you cannot visit the website or do not have internet access.
All Devices manufactured before April 26, 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
- C-Series S/T and AVAPS
- OmniLab Advanced+
Noncontinuous Ventilator
- SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Actions to take if you use the above 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.
- Register your device on the recall website www.philips.com/src-updates
- The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two issues.
- The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
- Call 1-877-907-7508 if you cannot visit the website or do not have internet access.
The company will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. Philips aims to address all affected devices in the scope of this correction as expeditiously as possible.
As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips recently launched the next-generation CPAP platform, DreamStation 2, is not affected by the issue. To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices, which are available in the U.S. and selected countries in Europe.
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