It is important to understand that Philips products manufactured by the affected business remain in use by customers, have strong reliability records and should not be taken out of service.
For perspective, with respect to the product issue that FDA focused on most intently in its most recent inspections of the Bothell facility – a component in our pre-2013 FRx and HS1 AEDs – out of 650,000 Philips AEDs with this component shipped before 2013, and an estimated 45,000 uses on patients, we are aware of approximately 12 instances in which the device failed to deliver all indicated shocks while in use on patients. Moreover, in all these cases, the AED still delivered at least one shock.
Also, Philips HeartStart public access AEDs shipped since January 2013 have a reliability record of approximately 99.9% per year.
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 Automated External Defibrillators (AEDs) to customers who have standardized on the HeartStart FR3 device.
Additionally, the company may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.
Per the terms of the Consent Decree, Philips may be required to notify customers concerning specific requirements, updates, or other pertinent information regarding a limited number of specified products.