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# Phillips Resumes Making Defibrillators Under Consent Decree
- URL: https://www.fdaweb.com/phillips-resumes-making-defibrillators-under-consent-decree/
- Published: 2020-04-24T12:00:00.000Z
- Updated: 2026-09-14T16:12:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146652

FDA has asked a Massachusetts federal court to lift portions of a consent decree affecting Royal Philips and its Emergency Care and Resuscitation business to allow the company to resume manufacturing and shipping external defibrillators for the U.S. market. The 11/2017-ordered decree ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5139841&searchWords=phillips%20decree&cate=S&stid=%241%24yH3.TF2.%249o%2FtFvscQjXfM9w5cgjLL0&ref=fdaweb.com)) suspended external defibrillator manufacturing at its Andover, MA, and Bothell, WA facilities. The decree followed inspections in 2015 and before that documented GMP issues, according to the company.

Earlier in 2017, Phillips [recalled](http://fdaweb.com/login.php?sa=v&aid=D5138285&searchWords=phillips&cate=S&stid=%241%24F41.qX5.%24iToZz.UsJRwzX61DnJKSW%2F&ref=fdaweb.com) its HeartStart MRx Monitor/Defibrillator due to battery and electrical issues. The device is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to those with sudden cardiac arrest. An FDA [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm548491.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) said that the battery and electrical connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. “A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death,” the notice said.

Under the decree, defibrillator manufacturing was to cease until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation. The decree allowed Philips to continue the manufacture and distribute certain automated external defibrillator models. Philips says it 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 defibrillator business and of Philips’ other patient care businesses by FDA.