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.
This recall has been terminated (originally issued October 12, 2006).
- Company
- Guidant Corporation
- Recall Initiated
- May 19, 2006
- Posted
- October 12, 2006
- Terminated
- December 31, 2006
- Recall Number
- Z-0002-2007
- Quantity
- 8
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Final software load did not occur prior to shipment of select programmers.
Distribution
Nationwide distribution --- including states of AR, MI, PA
Lot / Code Info
Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,
Root Cause
Other
Action Taken
Sales Representatives were asked to retrieve/return identified monitors.
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