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Guidant Zoom Latitude Programming System, Model 3120… recallZ-0002-2007 · Guidant Corporation · initiated May 19, 2006

Terminated All recalls posted in October 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Guidant Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

Sales Representatives were asked to retrieve/return identified monitors.

Recall details

Recall number
Z-0002-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 19, 2006
Posted by the FDA
Oct 12, 2006
Recalling firm
Guidant Corporation
Quantity
8
Product code
LWS
FDA submissions
P910077
Distribution
Nationwide distribution --- including states of AR, MI, PA

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.

Code information (models, lots, serial numbers)

Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,

Other devices under the same FDA submission

34 devices cleared under P910077 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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