Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1472-04

Zoll M Series Automated Defibrillator (AED)

ZOLL Medical Corporation / initiated 2004-08-02 / Terminated

Zoll Medical Corporation began a recall of Zoll M Series Automated Defibrillator (AED) on . The reason FDA records is "Visual Sreen display and audible prompt may not advise to 'Press Shock'". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1472-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZOLL Medical Corporation
Product
Zoll M Series Automated Defibrillator (AED)
Product code
MKT Hepatitis Viral B Dna Detection
Reason for recall
Visual Sreen display and audible prompt may not advise to 'Press Shock'
FDA 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 in commerce
5649 units
Distribution
Nationwide
Product codes and lots
Software Versions below 34.00