Device recall
Z-1931-2019: ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is…
FDA device recall · Class II · ZOLL Medical Corporation
Key facts
| Recall number (Z-number) | Z-1931-2019 |
|---|---|
| Recall event | 83109 |
| 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… |
| Product code | MKJ |
| Recalling firm | ZOLL Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160022 |
| FEI number | 1220908 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database