Medical Device recall notification (U.S. only) /
field safety notice (Outside of U.S.)

Philips Respironics

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Home > A message from David Ferguson

A message from David Ferguson

Executive Vice President, Philips Business Leader
Sleep and Respiratory Care

August 30, 2021

To the community of patients, providers and practitioners,

As part of our commitment for ongoing communication regarding the recent recall notification (U.S. only) / field safety notice (outside of U.S.) of certain products in our Sleep and Respiratory Care portfolio, I wanted to take this opportunity to share some important updates with you. 
 
In recent weeks, we have been actively working with global competent authorities and regulatory bodies to align on the remediation process. This process will enable the repair or replacement of the impacted devices while putting patient safety and speed of resolution as the top priorities. 
 
There are three other areas of update to share with you today:
 

Clinical insight

 

There has been a great deal of attention focused on the guidance Philips provided regarding the use of impacted devices, which can be once again found at philips.com/src-update. We must reiterate the guidance that patients should consult with their physicians regarding therapy options and continued use. 
 
We recognize that this recommendation, combined with the time required to finalize and execute this remediation plan can be challenging for our customers, physicians, and their patients. However, this advisory came after careful consideration of the clinical data available, along with the respect for every patient/physician relationship regarding personalized care. 
 
We will continue to offer any emerging data and guidance for physician consideration at
 philips.com/src-clinician-update.

Timing of remediation

 

Currently, we are processing the device serial number registrations that have been received and are actively working with global competent authorities on the remediation process. Our organization is working diligently to replace or repair devices as soon as possible. Based on current estimates of impacted devices worldwide, we are working towards completing this effort within approximately 12 months.  


We will continue to stay in communication with updates on any new developments and additional information regarding progress and timing. 

Manufacturing ramp-up

 

We are fully committed to addressing this issue on a global scale and have increased both our production capacity, as well as our service and repair capacity. Specifically, we have increased the production capacity of repair kits and replacement devices in Q3 2021 to 55,000 units per week and we aim to further increase that capacity to 80,000 units per week in Q4 2021. 
 
While we have made progress, we are conscious that timing and communication are critical. We will continue to share updates as we manage through this process, as well as keep current information posted
at philips.com/src-update.

On behalf of everyone at Philips, I thank you for your patience and your partnership, as we work through this, while keeping patient care at the heart of everything we do.

 

Sincerely,


David Ferguson

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