Recall Z-1472-04 ยท MKT Hepatitis Viral B Dna Detection
Zoll Medical Corporation
Zoll M Series Automated Defibrillator (AED)
| Date | Sep 17, 2004 (initiated Aug 2, 2004) |
| Status | Terminated |
| Reason | Visual Sreen display and audible prompt may not advise to 'Press Shock' |
| Root cause | Other |
| Action | Zoll Medical notified consignees by letter on 8/2/04 via Certified Mail. Users are advised of the problem and the softtware upgrade. |
| Quantity | 5649 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010257 | ZOLL M SERIES Zoll Medical Corp, Feb 28, 2001 |