FDA Device Recall Z-0002-2007: Guidant Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2007.

Recall Res Number

Z-0002-2007

Recalling Firm / Manufacturer

Guidant Corporation

FEI Number

2124215

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-05-19

Date Posted

2006-10-12

Date Terminated

2006-12-31

Product Code

LWS

Event Number

35672

Product Quantity

Product Description 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.

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

Action Details Sales Representatives were asked to retrieve/return identified monitors.

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

Code Information / Serial Numbers Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,

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Medical Device Recall: Z-0002-2007

Recall Parameters & Description

Related Establishments / Registrations

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