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.
The decree also includes quality system compliance provisions for medical devices produced by other Patient Care & Monitoring Solutions (PCMS) businesses at these two facilities. Philips will continue to manufacture and distribute these other PCMS devices. Medical devices and consumer products manufactured by other Philips businesses at these facilities are not affected by the decree.
Philips is committed to full compliance with the terms of the Consent Decree, and to fulfilling all necessary conditions to resume manufacture and shipping of affected products.