FDA Medical Device Recalls (openFDA)
Guidant Corporation: 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.
- Recall number
- Z-0002-2007
- Recalling firm
- Guidant 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.
- Status
- Terminated
- Initiated
- 2006-05-19
- Posted
- 2006-10-12
- Terminated
- 2006-12-31
- Reason
- Final software load did not occur prior to shipment of select programmers.
- Root cause
- Other
- Action
- Sales Representatives were asked to retrieve/return identified monitors.
- Quantity
- 8
- Distribution
- Nationwide distribution --- including states of AR, MI, PA
- Lot, serial or model codes
- Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790,
- 510(k) numbers
- not on file
- PMA numbers
- ["P910077"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28