Where is philips respironics
Additionally, the foam may off-gas chemicals during use. Unapproved cleaning methods may increase foam degradation. These issues could result in serious health concerns, including difficulty breathing and cancer. To see the full list of affected devices, consult the Philips Respironics Medical Device Recall notice.
It is estimated that there are 25 million Americans with sleep apnea, a sleep disorder that is treated using these medical devices. Many people who suffer from sleep apnea use CPAP breathing machines to ensure that their breathing is consistent and constant each night. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Successfully managing sleep apnea care.
Contact us. How can we help you? Contact information. Lucia St. Martin St. Outlying Islands U. Salutation Mr. Academic title. Business phone.
Job title. State or Province. Zip or Postal Code. Previous Next. By specifying your reason for contact we will be able to provide you with a better service. If you would prefer to receive a new machine through insurance, please check with your insurance company if you are eligible for a replacement machine due to recall or due to the purchase date of your current machine.
Please confirm any associated costs you may incur based on your deductible or co-insurance. If you are eligible and decide to replace your machine via insurance, please let us know so we can make arrangements for a new machine for you.
Please leave your full name and date of birth and insurance information so we can start the eligibility process. If we do not answer, please leave your full name and date of birth. We are experiencing a high call volume but will get back to you as soon as we can. It will require an office visit with your sleep medicine physician and new prescription. As of yet, there are no published scientific articles about the Phillips Respironics problem or the health risks that are outlined in the Philips recall website information.
We would like to give our patients some important information for use of your PAP therapy —. Food and Drug Administration and Health Canada. For more information regarding FDA recall classifications, please visit:. As a result of extensive ongoing analysis, on June 14, , the company issued a recall notification U. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue.
Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process.
Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.
For more information on the recall notification U. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification U. The company has developed a comprehensive plan for this correction, and has already begun this process. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.
Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. 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. Call if you cannot visit the website or do not have internet access.
Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. The products were developed according to the required standards and regulatory registrations at the time of initial release.
The Philips Quality Management System has been upgraded to reflect alignment with updated standards. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.
Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone , and certain environmental conditions involving high humidity and temperature. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored.
This factor does not refer to heat and humidity generated by the device for patient use. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. At this time, Philips is unable to set up new patients on affected devices.
Philips may work with new patients to provide potential alternate devices. In accordance with the Philips Quality Management System, the company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.
By clicking on the link, you will be leaving the official Royal Philips Healthcare "Philips" website. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites.
Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Medical Device Recall Notification.
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