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PHILIPS Respironics CPAP, BiPAP and Ventilator Recall Info

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To check the status of your Philips recall replacement unit - click here

BCMA Review
Philips Respironics has recalled the following affected devices manufactured between 2009 and April 26, 2021.

What we know:

The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device's air pathway. If this occurs, black debris from the foam or certain chemicals released into the device's air pathway may be inhaled or swallowed by the person using the device.

• We do not know what this may do long term and the FDA is currently reviewing the product.
• Using any type of ozone based cleaner or UV based light worsens the breakdown of the foam.
• Philips is planning to repair each and every device, so once your device is registered, they will contact you. We do not know how long this will take. We do not have replacement devices in our office.
  
  

What we are recommending:

• Philips has stated that if the benefit outweighs the risk for using your affected device, they state the device can be continued. This may include circumstances in which there is life-threatening illness or circumstances (use of ventilators, commercial drivers who rely on their machines for safety reasons, or that stopping a device may cause severe disabling daytime symptoms and/or cardiac risk.)
• Stop using any ozone/UV cleaners and follow the device instructions for manual cleaning.
• Use a prior functional CPAP device that is not on the recall list.
• Look into alternative therapies including weight loss, positional therapy, or an oral appliance.
• Sleeping on your side, elevating your bed, avoiding sedating substances like alcohol and/or using mouth guards may help reduce some symptoms in the meantime.
• Check with your insurance company to see if you are eligible for a replacement machine covered by your insurance.
• Look into an out-of-pocket CPAP device (new or refurbished) sold through CPAP.com or 1800CPAP.com that are not on the recall list.
• Remain patient if still waiting on the recall list, as we cannot do anything to speed up this process.
  
  

Devices that are affected include:

• Trilogy 100 Ventilator
• Trilogy 200 Ventilator
• Garbin Plus, Aeris, LifeVent Ventilator
• A-Series BiPAP Hybrid A30 (not marketed in US)
• A-Series BiPAP V30 Auto Ventilator

• A-Series BiPAP A40 (not marketed in US)
• A-Series BiPAP A30 (not marketed in US)
• ***CPAP and BiLevel PAP Devices-All Affected Devices Manufactured Before 26 April 2021,
  All Device Serial Numbers
• E30
• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C Series ASV, SIT, AVAPS
• OmniLab Advanced Plus - In-Lab Titration Device
• SystemOne (Q series)
• DreamStation CPAP, Auto CPAP, BiPAP
• DreamStation G<;) CPAP, APAP
• Dorma 400, 500 CPAP
• REMStar SE Auto CPAP
  
  

Register via this link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

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Register via this link:
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
Check status of your Philips recall replacement unit via this link:
https://www.philipspatientportal.expertinquiry.com/​

​Useful Links

• Philips Respironics CPAP, BiPAP, and Ventilator Recall - Frequently Asked Questions
• Philips Medical Device Recall Notifications - Device registration and recall contact information    
  
  

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