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.
FDA Recall Z-1931-2019 · Posted None
Recalling FirmZOLL Medical Corporation
Recall StatusOpen, Classified
Product CodeMKJ
Date Initiated2019-06-12
Product Quantity1,969
Reason for Recall
There is a potential for the device to fail to deliver energy to the patient.
Firm Action
Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. The letter identified the affected product, problem and actions to be taken.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spain, Thailand, Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.