Recall Z-1931-2019— ZOLL Medical Corporation

Class II FDA medical device recall by ZOLL Medical Corporation, initiated 2019-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.. Reason: There is a potential for the device to fail to deliver energy to the patient..

Recalling firm

ZOLL Medical Corporation

Classification

Class II

Status

Ongoing

Initiated

2019-06-12

Firm location

Chelmsford, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.