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Philips Respironics Voluntary Recall of Ventilators, CPAP and Bi-Level Machines

Wednesday, June 16, 2021 @ 12:06 PM  posted by jbuytaert
Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.
These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of these issues.
ALL DEVICES MANUFACURED BEFORE APRIL 26, 2021, ALL SERIAL NUMBERS:
Trilogy 100
Trilogy 200
Garbin Plus, Aeris, LifeVent
A-Series BiPAP Hybrid A30
A-Series BiPAP A40
A-Series BiPAP A30
E30
DreamStation ASV
Dreamstation St, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
SystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto
Immediate Actions to be taken by You, the User:
1. 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 this letter.
2. Register your device on the recall website http://www.philips.com/src-update
3.  The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues.
4.  The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
5. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.
Permanent Corrective Action to be Taken by the Company:
Philips is deploying a permanent corrective action to address the two (2) issues described in this Recall Notice. As part of the registration process above, you will be provided information on the next steps to implement the permanent solution.
Other Information:
If you need any further information or support concerning this issue, please contact the recall support hotline or visit the website:
1-877-907-7508
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regular mail or fax.
This notice has been reported to the appropriate Regulatory Agencies.
Philips regrets any inconveniences caused by this problem.
Sincerely,
Rodney Mell
Head of Quality and Regulatory
Philips Respironics – Sleep & Respiratory Care

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