Reminder: Premarket approval (PMA) regulation due

 

Important information for all U.S. AED and professional defibrillator users

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 will impact ZOLL® M Series® and E Series® monitor/defibrillator customers. 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 effective February 3, 2022. ZOLL will continue to support these legacy devices as parts availability allows. Procurement of replacement parts is limited and as a result this may affect product service offerings. In accordance with previous announcements, the M Series replacement battery and EtCO2 sensor are no longer being manufactured.

What action should you take?

  1. Take inventory of your AEDs and professional defibrillators and check them against the FDA-approved devices list.
  2. 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.

This is ZOLL. We are ready.

 

FDA-Approved Devices

For Hospitals
and Clinics

For EMS
Professionals

For Public
Areas

For Military
Professionals

For information on upgrade and financing options: