Effective February 3, 2022: All AEDs and professional defibrillators must be FDA-approved under the premarket approval (PMA) regulation.
The U.S. Food and Drug Administration (FDA) notified all AED and professional defibrillator owners, users, and prescribers that effective February 3, 2022, accessories for non-FDA approved AEDs and professional defibrillators will no longer be supported by the manufacturer.
This regulation impacts all AEDs and professional defibrillators that do not carry FDA premarket approval. In accordance with the FDA requirement, accessories (including, but not limited to, batteries, cables, hardware, and therapy electrodes) and service will no longer be available for these devices.
What action should you take?
- Take inventory of your AEDs and professional defibrillators and check them against the FDA-approved devices list.
- If any of your devices are not included on the FDA-approved devices list, contact us for information about how you can transition to FDA-approved devices.
We want to help you remain focused on improving patient outcomes by providing innovative technology for resuscitation and acute critical care and maintaining rigorous adherence to regulatory compliance programs.
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FDA-Approved Devices
For information on upgrade and financing options:
- Contact your local ZOLL sales representative or authorized distributor
- Call ZOLL Customer Service: 1-800-804-4356-
- Submit the FDA-approved devices Information Request Form