Philips AED Recall Notification

RE: Philips Healthcare Medical Device Recall/Notification

We are posting this notice to inform you that you will may be receiving a Medical Device Recall/Notification in the mail from Philips Healthcare in the near future.  This letter will fully explain the purpose of the recall including all details of any actions you will need to take, if any at all, pertaining to one or more of the Philips HeartStart AEDs you have purchased in the past.  This recall affects AEDs purchased between 2002 and 2012.  The document will discuss your options for replacement of the device if it is deemed necessary.

It is important to note, this recall has only affected a very small number of AED devices but it important to take action if required.

To view the notification in its entirety, see below.    If you have any questions at all, you can call us at 866-242-8010 or email at [email protected].

******************************************************************************************************************************************************************************************************************************

November 1, 2017
Dear Customers,

On October 31, 2017, a Federal court formally approved the consent decree that Philips signed with the U.S. government on October 11, 2017. This consent decree concerns required quality system improvements at the company’s defibrillator manufacturing facilities in Andover, Massachusetts, and Bothell, Washington. The decree is based on past inspections of these facilities in and before 2015.
The consent decree requires Philips to suspend the manufacture and distribution of certain external defibrillators manufactured at these facilities until the FDA certifies, through inspection, the facilities’
compliance with the Quality System Regulation. Philips must also provide additional safety information to purchasers of Q-CPR and to purchasers of certain automated external defibrillators manufactured prior to 2013.

Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart Onsite automated external defibrillators (AEDs) in order to meet public health needs globally. Under certain
conditions, the company is also allowed to manufacture and ship HeartStart FR3 AEDs to customers who have standardized on the HeartStart FR3 device. Philips will provide these devices to help save lives. Philips can also continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction. Additionally, Philips is permitted to manufacture and ship HeartStart FRx and FR3 AEDs for export from the U.S. once certain conditions are met.

Please know that we take this matter extremely seriously. The company is committed to our customers in the emergency and resuscitation business and to fulfilling the terms of the decree, building on corrective actions we have taken since 2015 to address these issues. We will continue on the journey that we started in 2015 to enhance our quality management systems throughout our organization in key areas of manufacturing and related core functions. We are very proud that our defibrillators save lives daily, with an extremely high reliability record of over 99.9% for our public access AEDs shipped since January 2013 and, it is important to note that Philips defibrillator products currently in use are recommended by Philips to remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients.

We embrace this opportunity to make lasting change and to live up to our commitment to you. We are confident that Philips will emerge from this even stronger than before.
We sincerely apologize for any delays and regret any inconveniences this may cause you. In the days ahead, we look forward to discussing how we may best address your needs as our valued customer.

Sincerely,

Matt Johnson
Vice President Sales
Emergency Care & Resuscitation
Philips Healthcare

Cited by: CF Medical, Inc and Philips Healthcare