Date Initiated by Firm |
December 17, 2002 |
Date Posted |
February 06, 2003 |
Recall Status1 |
Terminated 3 on April 21, 2004 |
Recall Number |
Z-0548-03 |
Recall Event ID |
25245 |
510(K)Number |
K011388
|
Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
|
Product |
Zoll AED Plus Defibrillator (Automatic External Defibrillator) |
Code Information |
Serial Numbers: X02F000812 through X02K007486 |
Recalling Firm/ Manufacturer |
Zoll Medical Corporation 32 Second Avenue Burlington MA 01803
|
For Additional Information Contact |
Paul Dias 781-265-9413
|
Manufacturer Reason for Recall |
Defibrillator may fail to function due to false detection of safety fault condition
|
FDA Determined Cause 2 |
Other |
Action |
Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts. |
Quantity in Commerce |
5,597 units |
Distribution |
Nationwide to : Hospitals, EMT, Police and Fire Rescue |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORP.
|