Company: Zoll Medical
Date of Enforcement Report 7/2/2008
Class:ll
PRODUCT
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008
REASON
Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.
RECALLING FIRM/MANUFACTURER
Zoll Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on January 14, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,018 units
DISTRIBUTION
Nationwide and Internationally
