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Philips U.S. PMA Information

Your continued satisfaction with Philips AEDs and Monitor-Defibrillators is very important to us and we want to ensure your confidence in the reliability of our solutions. As recently announced by the United States Food and Drug Administration (FDA), accessories for AEDs without premarket approval (PMA) applications submitted by February 3, 2020 cannot be sold or delivered after February 3, 2021 in the United States. This FDA notice affects the following Philips AEDs and defibrillators with an integrated AED mode: HeartStart FR2, HeartStart XL/XL+, and MRx. In accordance with FDA’s notice, Philips will no longer be able to provide AED accessories for these devices after February 3, 2021. For some of these devices that have reached their end of life, the end-of-shipment dates for accessories will be prior to February 3, 2021. Please refer to the table below for additional information.

What action should you take?
  • Take inventory of your AEDs and monitor-defibrillators and check them against the FDA-approved devices list
  • If any of your devices are not included on the FDA-approved devices list, contact us for information about how you can transition to FDA-approved devices
  • For customers outside the United States, these timelines do not apply

The PMA status for Philips end of production solutions is below:

Device
Status
HeartStart FR2 AED
HeartStart FR2/FR2+ and associated accessories, with the exception of pads and batteries, have reached or will reach end-of-life/end-of-shipment dates in the United States before February 3, 2021. In the United States, orders for FR2/FR2+ pads and batteries can be placed until December 31, 2020 and orders will be fulfilled, as inventory allows, through February 3, 2021.
HeartStart MRx monitor/defibrillator
In May 2017, Philips discontinued the HeartStart MRx Advanced Life Support (ALS) monitor-defibrillator. The FDA recently provided an update on premarket approval (PMA) policy guidelines for Automated External Defibrillators (AEDs). Based on these updated guidelines, in the United States Philips will continue to offer HeartStart MRx batteries, pads, and hands free cables, only until February 3, 2021. Orders for MRx batteries, pads, and hands free cables must be placed by December 31, 2020 in the United States only. These items can continue to ship outside the United States beyond this date.
HeartStart XL defibrillator/monitor
Philips HeartStart XL defibrillator/monitors’ related accessories and disposables have reached or will reach their end-of-life/end-of-shipment dates before February 3, 2021 in the United States.
HeartStart XL+ defibrillator/monitor
Philips HeartStart XL+ defibrillator/monitors’ battery, pads and hands free cable have reached or will reach their end-of-life/end-of-shipment dates before February 3, 2021 in the United States only. For customers outside of the United States, battery, pads and hands free cable will continue to be shipped after this date.
The HeartStart Onsite HS1, HeartStart Home, HeartStart FRx and HeartStart FR3 are not affected by FDA’s announcement and accessories and disposables for these devices will continue to be provided.

FAQ

 

Q: What is PMA?

 

A: Premarket approval (PMA) is the most stringent type of premarket submission required by U.S. Food and Drug Administration (FDA). PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
 

In February 2015, the FDA issued a new regulation requiring that manufacturers submit PMAs for new and existing AEDs and accessories.

 

Q: The HeartStart MRx is not listed as a PMA approved device on the FDA website. Is this device not FDA approved?

 

A: The MRx is not PMA approved. The MRx devices in the United States that were legally sold under a 510(k) clearance can continue to be used by their owners. Philips will continue to offer HeartStart MRx batteries, pads, and hands free cables, only until February 3, 2021 in the United States.

 

Q: Must the HeartStart MRx be removed from customer sites in the United States?

 

A: HeartStart MRx devices installed at customer sites may remain in service.

Please refer to the letters for more details regarding PMA status for Philips end of production solutions.

Please contact your Philips representative for assistance or additional information.

Additional information

For more information regarding the Philips Defibrillator Consent Decree, please click here.