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

Philips Respironics

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Updates to Questions and Answers

August 27, 2021

Is this a recall? Have regulatory authorities classified the severity of the recall?

The issuance of the notification is a recall in the U.S., and field safety notice in Outside of U.S., according to regulatory agency criteria.


This recall notification / field safety notice has been designated a Class I recall by both the U.S. Food and Drug Administration and Health Canada.

 

For more information regarding FDA recall classifications, please visit:

 

For the FDA's recommendations regarding this Class I recall, please visit:

When will the correction for this issue begin? How long will it take to address all affected devices?

The company will replace the current sound abatement foam with a new material that is not affected by this issue. 


At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. 


Philips will provide further clarity on projected dates for implementation of the correction to begin when this information is available. 


The process for preparing the corrections indicated in the recall notification (U.S. only) / field safety notice (International Markets) has begun.


This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.


Philips is notifying regulatory agencies in the regions and countries where affected products are available. 


Our global repair and replacement program for affected devices is being implemented in accordance with appropriate regulatory requirements in each market, which may, in some markets, include review and/or authorization by the relevant regulatory agencies. 


We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction.

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