Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets).

 

The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:

 

• For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
• For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
• Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets) website, www.philips.com/SRC-update.
  • The website provides current information on the status of the recall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues.
  • The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process.
  • Call 877-907-7508 if you cannot visit the website or do not have internet access.

 

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.

 

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, 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.