CompanyGuidant Corporation
Date of Enforcement Report:11/1/2006
Class:ll
PRODUCT
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007
REASON
Final software load did not occur prior to shipment of select programmers.
CODE
Serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,
RECALLING FIRM/MANUFACTURER
Guidant Corporation, Saint Paul, MN, by visits on June 5, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide
