ZOLL AED PRO Automated External Defibrillator Product Usage: The AED… — Class II medical device recall Z-1931-2019
Ongoing recall by ZOLL Medical Corporation, reported 2019-07-10, distributed nationwide. There is a potential for the device to fail to deliver energy to the patient.
| Recall number | Z-1931-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Medical Corporation, Chelmsford, MA, United States |
| Recall initiated | 2019-06-12 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BR, CA, CN, DE, DK, ES, FR, GB, ID, IT, JP, NZ, PA, RU, SA, SG, TH, TW |
| Quantity | 1,969 |
| UPC / GTIN / UDI-DI | 00847946015138, 00847946016128, 00847946016135, 00847946016142, 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 and 475 more |
| Model numbers | 70010400499991010, 90010200499991010, 90010202499991010, 90010400499991010, 90010600499991010 |
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 for recall
There is a potential for the device to fail to deliver energy to the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1931-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.