Drug recall
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate…
FDA recall event 83109 · Class II · ZOLL Medical Corporation
Key facts
| Event ID | 83109 |
|---|---|
| Recall numbers | Z-1931-2019 |
| Recalling firm | ZOLL Medical Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for the device to fail to deliver energy to the patient. |
| Initiation date | Jun 12, 2019 |
| Report date | Jul 10, 2019 |
| City | Chelmsford |
| State | MA |
| Country | United States |
| FEI number | 1220908 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: