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# Philips to Halt Defibrillator Manufacturing Under Consent Decree
- URL: https://www.fdaweb.com/philips-to-halt-defibrillator-manufacturing-under-consent-decree/
- Published: 2017-10-11T12:00:00.000Z
- Updated: 2026-09-14T22:55:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139841

Philips North America has agreed to a consent decree with FDA that will see the company suspending external defibrillator manufacturing at its Andover, MA, and Bothell, WA facilities. The decree follows inspections in 2015 and before that documented GMP issues, according to the company.

Earlier this year, Phillips [recalled](https://www.fdaweb.com/phillips-recalls-heartstart-defibrillator/) 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 will cease until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation. The decree allows Philips to continue the manufacture and distribute certain automated external defibrillator models. Philips will also be able to export certain devices once certain requirements have been met, according to the company. “The decree provides for increased scrutiny, for a period of time, of the compliance of the other patient care businesses at these facilities with the Quality System Regulation.” The decree will become effective when it is approved by the U.S. District Court for Massachusetts.