The immediate effect of the Consent Decree was that the Emergency Care & Resuscitation (ECR) business suspended shipping and manufacturing all of its products, including its defibrillator products, until the FDA determined that ECR complies with the Agency’s quality systems regulation.
Under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue manufacturing and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators (AEDs) in order to meet public health needs globally. Philips has resumed shipments of its HeartStart Home and HeartStart OnSite AEDs.
Under certain conditions, Philips may also manufacture and ship a limited number of Philips HeartStart FR3 devices to customers who have standardized on HeartStart FR3 devices.
To meet the needs of our global customers, Philips is permitted to manufacture and ship HeartStart FRx and HeartStart FR3 AEDs for export from the U.S. once certain conditions are met. Philips has started resuming shipments of the HeartStart FRx and HeartStart FR3 AEDs outside the U.S. Additionally, the company may also continue to provide necessary consumables and accessories for Philips defibrillator products globally, without restriction. Philips has resumed shipments of consumables and accessories for its defibrillator products.
As noted in the terms of the Consent Decree, Philips may continue to service existing devices, as well as continue R&D efforts and participation in clinical trials.