If you are a patient using a Philips/Respironics device, please call our Patient Interaction Team at 1-800-345-6443 then press #, or email them at pcms.support@philips.com. If you are contacting us about the Medical Device Recall Notification for Continuous and Non-continuous Ventilators please call 1-877-907-7508 for support or visit our ...
In addition, Philips Respironics continues to utilize its current mobile application, DreamMapper, to send notifications to patients and consumers utilizing the application with information regarding the field action.
877-907-7508 On June 14, 2021, Philips issued a recall notification for the United States for specific affected ventilation and sleep apnea devices. The notification informs patients, users and customers of potential impacts on patient health and clinical use related to this issue.
To date, Philips Respironics has shipped a total of more than 650,000 replacement devices to customers in the US, and aims to complete the repair and replacement program in the fourth quarter of 2022.
After you enter your device's serial number during registration, the site will tell you if it is one of the recalled models . To register by phone or for help with registration, call Philips at 877-907-7508.
FDA Actions 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).
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.
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.
Philips has said they have a comprehensive repair and replace program for recalled CPAP machines. On Sept. 1, 2021, Philips announced that it received its authorization from FDA to begin replacing the problematic foam in affected devices or replacing them with new DreamStation 2 models in the U.S.
Victims may ask, “Is there a class action lawsuit against Phillips CPAP machines?” The answer to that question is “yes.” Since June, there has been a flurry of different lawyers filing claims for victims, and a class action lawsuit was filed in Massachusetts.
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.
On June 14, 2021, Philips announced a voluntary recall notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines*. 2. the sound abatement foam may off-gas certain chemicals.
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.
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.
1-800-722-9377.
If you use a CPAP machine, speak to your doctor before stopping your use of the device. Your medical team might recommend continuing to use the device, as it might be less detrimental than stopping. Speak to your lawyer to determine if your device is defective and affected by the recall.
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1. Gabriel MH, Noblin A, Rutherford A, et al. Data breach locations, types, and associated characteristics among US hospitals. Am J Manag Care. 2018;24 (2):78-84.
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.