Company: Zoll Medical Corp
Date of Enforcement Report: 4/24/02
Class: I
PRODUCT
a) Zoll M Series Advisory Defibrillator. Recall # Z-0893-2;
b) Zoll M Series AED Defibrillator (semi automatic defibrillator).
Recall # Z-0894-2.
REASON
Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock.
CODE
a) Serial Numbers: T98F00046-T01K27762 with System Software Version below 30.00
b) Serial Numbrs: T98F0092-T01J27533 with System Software Version below 30.0.
RECALLING FIRM/MANUFACTURER
Zoll Medical Corp., Burlington, MA, by letter on December 18, 2001.Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13,667.
DISTRIBUTION
Nationwide and worldwide.
