Z-0002-2007

Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac...

Name: Z-0002-2007 Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac...
Creator: Guidant Corporation
Published: 2006-05-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-19 / Terminated / root cause: software

FDA source

Guidant Corporation began a recall of Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with... on 2006-05-19. The reason FDA records is "Final software load did not occur prior to shipment of select programmers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0002-2007
Status: Terminated
Initiated: 2006-05-19
Posted: 2006-10-12
Terminated: 2006-12-31
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Final software load did not occur prior to shipment of select programmers.
Root cause tag: software
FDA root cause: Other
Action: Sales Representatives were asked to retrieve/return identified monitors.
Quantity in commerce: 8
Distribution: Nationwide distribution --- including states of AR, MI, PA
Product codes and lots: Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)