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For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Call 877-907-7508 if you cannot visit the website or do not have internet access.
While our patients are registering their devices, Philips is working to release replacement product and repair kits within each country and begin remediation. After your affected device has been registered, Philips will confirm your information and work to provide a replacement device.
You should register your device at https://www.philipssrcupdate.expertinquiry.com. Philips Respironics will send you a new device when one is available. This may take up to a year.
Philips issued a voluntary recall on June 14th, 2021, due to sound-reducing foam in its manufactured respiratory devices that could potentially break down and enter users' airways or release harmful chemicals. In June, Philips Respironics reported low complaints and no serious harm documented from this recall.
Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks.
The FDA reviewed and concurred with Philips' Respironics plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations) and DreamStation ST, ASV, AVAPS (All Configurations).
The best way to know if your device is included in the recall is to register your machine for the recall. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number.
Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines.
If you're using one of the machines that has been recalled by the FDA, you might think that you need to immediately stop using it, but that might not be helpful for your sleep apnea. As advised by the FDA, you shouldn't stop using your CPAP device just because it's listed in the recall.
Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
around $100,000 to $500,000Some attorneys speculate that victims of illnesses resulting from the use of recalled Philips continuous positive airway pressure (CPAP) machines may reach settlement amounts of around $100,000 to $500,000, but it's still unknown exactly how much these settlements will be worth.
For patients using life-sustaining mechanical ventilator devices, we recommend patients do not stop or alter prescribed therapy until after talking with your ordering provider.
Irritation (skin, eyes, and respiratory tract), inflammatory response, headache, unpleasant smell, dizziness, asthma, along with possible longer term adverse effects, including “possible toxic and carcinogenic effects”, related to chemicals released from the foam insulation (see below).
Currently, there is a recall for the Philips Respironics CPAP and BiPAP devices. The U.S. Food and Drug Administration (FDA) issued a recall for these devices from Philips Respironics in June 2021: E30.
Please contact your Philips Service representative, or Philips Customer Care Solutions Center at. 1-800-722-9377 with questions. Click here to see 2021 US holiday schedule.
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Call 877-907-7508 if you cannot visit the website or do not have internet access.
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.
Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.
Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices. Philips aims to address all affected devices within the scope of this correction as expeditiously as possible. Amsterdam, the Netherlands – Following the company update on April 26, 2021, ...
Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips’ organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.
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 scope of this correction as expeditiously as possible.#N#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 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, that are available in the US and selected countries in Europe.