{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Chelmsford", "state": "MA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "83109", "recalling_firm": "ZOLL Medical Corporation", "address_1": "269 & 271 Mill Road", "address_2": "N/A", "postal_code": "01824", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "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.", "recall_number": "Z-1931-2019", "product_description": "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.", "product_quantity": "1,969", "reason_for_recall": "There is a potential for the device to fail to deliver energy to the patient.", "recall_initiation_date": "20190612", "center_classification_date": "20190703", "report_date": "20190710", "code_info": "Part Numbers: 90010200499991010, 90010400499991010, 70010400499991010, 90010202499991010, 90010600499991010; GTIN: 00847946016128, 00847946016142, 00847946015138, 00847946016135, 00847946016166 Serial Numbers: AA17C041915 AA17C041916 AA17J043664 AA17J043666 AA17J043670 AA17J043671 AA17J043672 AA17J043673 AA17J043674 AA17J043675 AA17J043682 AA17J043683 AA17J043725 AA17J043813 AA17J043814 AA17J043817 AA17J043820 AA17J043825 AA17L044265 AA18B044867 AA18B044868 AA18B044869 AA18B044870 AA18B044871 AA18B044872 AA18B044873 AA18B044874 AA18B044875 AA18B044877 AA18B044878 AA18B044879 AA18B044880 AA18B044881 AA18B044882 AA18B044883 AA18B044884 AA18B044885 AA18B044886 AA18C044887 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