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Terminated

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.

FDA Recall Z-0002-2007 · Posted 2006-10-12

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2006-05-19
Date Terminated2006-12-31
Product Quantity8

Reason for Recall

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

Firm Action

Sales Representatives were asked to retrieve/return identified monitors.

Root Cause

Other

Distribution Pattern

Nationwide distribution --- including states of AR, MI, PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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