News | Defibrillator Monitors | April 24, 2020

FDA Lifts Injunction on Philips Defibrillators

Injunction on Philips AEDs has been in place since November 2017

 

 

The U.S. Food and Drug Administration (FDA) has lifted its injunction prohibiting the manufacturing and shipping of external defibrillator AEDs in the United States. 

April 24, 2020 — The U.S. Food and Drug Administration (FDA) has lifted its injunction prohibiting the manufacturing and shipping of external defibrillators for the United States. 

Royal Philips said its emergency care and resuscitation (ECR) business has been operating under a consent decree with the FDA since November 2017. Under the terms of the consent decree, Philips was required to suspend manufacture and distribution of its defibrillators from specific Philips facilities in the U.S., pending FDA certification via inspection of the facilities’ compliance with Quality System Regulation. However, in order to ensure uninterrupted availability of these life-saving devices in the U.S., the consent decree included exemptions for specific Philips automated external defribrillator (AED) models to continue to be manufactured and shipped, in addition to providing necessary device servicing, accessories and consumables.

Philips continues to comply with the terms of the consent decree, which remains in effect, and includes ongoing regulatory compliance monitoring and facility inspections of the ECR business and of Philips’ other patient care businesses by the FDA.

“The injunction lift is an important milestone for Philips, as we have enhanced the regulatory compliance processes in our ECR business and throughout the company,” said Frans van Houten, CEO of Royal Philips. “Providing our customers with safe and reliable products and solutions remains our highest priority, and I am proud that our AEDs save lives daily, with their very high reliability record.”

For more information: https://www.usa.philips.com/healthcare/solutions/emergency-care-resuscitation/automated-external-defibrillators

Related Content

News | Defibrillator Monitors

June 23, 2020 — Philips announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for ...

Home June 23, 2020
Home
News | Defibrillator Monitors

January 13, 2020 — Stryker announced it is launching a voluntary field action on specific units of the LifePAK 15 ...

Home January 13, 2020
Home
Technology | Defibrillator Monitors

June 19, 2019 — Philips announced the U.S. Food and Drug Administration (FDA) has approved the company’s premarket ...

Home June 19, 2019
Home
News | Defibrillator Monitors

April 5, 2019 — Medical device startup HeartHero was the winner in the Innovation Challenge at the 2019 American College ...

Home April 05, 2019
Home
Feature | Defibrillator Monitors

February 4, 2019 — Stryker announced Feb. 1, the company is launching a voluntary field action on specific units of the ...

Home February 04, 2019
Home
Feature | Defibrillator Monitors | Michael J. Mirro, M.D.

Following the Vest Prevention of Early Sudden Death Trial (VEST) presentation at the 2018 American College of Cardiology ...

Home July 10, 2018
Home
News | Defibrillator Monitors

June 27, 2018 — Wearable cardioverter defibrillators may be a safe and effective alternative to surgically implanted ...

Home June 27, 2018
Home
News | Defibrillator Monitors

April 16, 2018 — The skin presents a formidable barrier to life-saving defibrillators, but a team of students from Rice ...

Home April 16, 2018
Home
News | Defibrillator Monitors

October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ...

Home October 16, 2017
Home
Technology | Defibrillator Monitors

April 24, 2017 — Physio-Control announced April 19 that the company’s HeartSine samaritan PAD 360P (SAM 360P) fully ...

Home April 24, 2017
Home
Subscribe Now