ClearanceBrief
Recall Z-0548-03 ยท MKJ Automated External Defibrillators (Non-Wearable)

Zoll Medical Corporation

Zoll AED Plus Defibrillator (Automatic External Defibrillator)

DateFeb 6, 2003 (initiated Dec 17, 2002)
StatusTerminated
ReasonDefibrillator may fail to function due to false detection of safety fault condition
Root causeOther
ActionZoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts.
Quantity5,597 units
DistributionNationwide to : Hospitals, EMT, Police and Fire Rescue
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011388ZOLL PAD
Zoll Medical Corp, Mar 25, 2002