FDA Device recall Z-1931-2019
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillati…
- FDA Device
- Class II
- ongoing
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillati… by Zoll Medical, citing there is a potential for the device to fail to deliver energy to the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1931-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-06-12 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zoll Medical |
| Distribution | US |
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
There is a potential for the device to fail to deliver energy to the patient.
Identifiers
| code_info | Part Numbers: 90010200499991010, 90010400499991010, 70010400499991010, 90010202499991010, 90010600499991010;…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 AA18C044888 AA18C044889 AA18C044890 AA18C044891 AA18C044892 AA18C044893 AA18C044894 AA18C044895 AA18C044896 AA18C044897 AA18C044898 AA18C044899 AA18C044900 AA18C044901 AA18C044902 AA18C044903 AA18C044904 AA18C044905 AA18C044906 AA18C04 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1931-2019%22
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