Recall Z-1931-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation
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 p
| Date | Jun 12, 2019 |
| Status | Open, Classified |
| Reason | There is a potential for the device to fail to deliver energy to the patient. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 1,969 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.