What is the latest update on the recall?
Click here for important Philips updates.
What is Philip Respironics medical device recall?
Medical Device Recall Notice (June 14, 2021)
What is Philip Respironics medical device recall date?
Monday June 14th, 2021
Why did Philip Respironics issue the medical device recall?
The concern relates to the polyester-based polyurethane (PE-PUR) sound abatement foam used in
Philips Continuous and Non-Continuous Ventilators. The PE-PUR foam may degrade into particles which
may enter the device’s air pathway and be ingested or inhaled by the user, and the PE-PUR foam may
off-gas certain chemicals.
What devices are affected by the recall?
The medical device recall applies to Philips Continuous and Non-Continuous Ventilators (certain CPAP,
BiLevel PAP and Ventilator Devices). This includes all devices manufactured before April 26th, 2021.
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use: |
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| Continuous Ventilator, Non-life Supporting: |
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| Non-continuous Ventilator: |
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| Continuous Ventilator: |
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| Continuous Ventilator, Minimum Ventilatory Support, Facility Use: |
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| Continuous Ventilator, Non-life Supporting: |
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Which Philips Respironics products are not impacted by the recall?
- DreamStation 2
- M-Series
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- BiPAP A40 EFL
- BiPAP A40 Pro
- Omnilab (original based on Harmony 2)
- Dorma 100, Dorma 200, & REMStar SE
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
How Do I Know if my machine is recalled?
Register your machine. Philips Respironics will let you know if your machine is included in the recall during this process. A confirmation number will be provided. Save the confirmation number for your records and you will receive information about the next steps in the recall process from Philips Respironics.
What is Philip Respironics asking users/patients to do?
Their latest update recommends that customers to talk to their doctor about the possibility of staying on therapy with their current machine. Philips is recommending patients to halt use of ozone-related cleaning products and adhere to their device manual for approved cleaning methods. Additionally, Philips is reminding patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
What if my physician recommends, I continue my therapy, but I do not have a replacement device?
If your physician decides you must continue using one of the affected devices, Philips suggests
seeking advice from your physician to what your options are.
Can I get a refund for my machine?
In compliance with Respironics mandate and standard recall practices, refunds are not issued for affected machines.
How do I get a replacement device?
Philips Respironics has set up a website where you can register your current device. Register your device(s) here: www.philips.com/src-update. Contact your DME provider for the latest updates on your replacement status.
Where can I find the serial number for my device?
The website www.philips.com/src-update supplies instructions on how to find your device Serial Number and will guide you through the registration process.
Does Philips have contact information if I do not have internet access?
Call Philips Respironics at 1-877-907-7508 if you cannot visit the website or do not have internet access.
How long will it take for Philips to fix this recall?
Philips 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.
Why is everything taking so long?
Millions of machines are affected in this recall, and it is not a small feat to work out. In addition to that, there is a global software chip supply storage. Computer chips are found cars, phones, computers, and CPAP machines. Global software chip shortage is due to a variety of reasons including the pandemic and labour shortages. If that is not enough, there is a global cargo backlog. Imported cargo shipments to North America are at record levels and ports have a backlog of ships waiting to be offloaded.
I have been waiting months, what happens next?
Contact your DME for the latest updates on your replacement status.
For immediate assistance, on any further information or support concerning this recall/issue, please contact Philips Respironics recall support hotline or visit the website: 1-877-907-7508 www.philips.com/src-update.