The immediate effect of the Consent Decree is that the Emergency Care & Resuscitation (ECR) business is to suspend shipping and manufacturing all of its products, including its defibrillator products, until the FDA determines that ECR complies with the Agency’s quality systems regulation.
At this time, under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs.
Under certain conditions, Philips may also manufacture and ship Philips HeartStart FR3 devices to customers who have standardized on HeartStart FR3 devices.
Additionally, the company may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.
As noted in the terms of the Consent Decree, Philips may continue to service and upgrade existing devices, as well as continue R&D efforts and participation in clinical trials.
Our focus remains on rapidly and effectively returning Philips’ defibrillator manufacturing sites to consistent compliance with quality regulations, as we renew our culture of quality.