FDA Device

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. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

Hazard

Final software load did not occur prior to shipment of select programmers.

What You Should Do

Remedy

Sales Representatives were asked to retrieve/return identified monitors.

Products

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. Gu
Brand
Guidant Corporation
UPC
Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,

Units Affected

8