Recall Z-0002-2007 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
| Date | Oct 12, 2006 (initiated May 19, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.