Class 2 Device Recall Zoll AED Plus Defibrillator

• Date Initiated by Firm: December 17, 2002
• Date Posted: February 06, 2003
• Recall Status: Terminated 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: 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.