Z-3091-2011

Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer...

Name: Z-3091-2011 Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer...
Creator: Advanced Neuromodulation Systems
Published: 2009-06-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-06-02 / Terminated / root cause: software

FDA source

Advanced Neuromodulation Systems began a recall of Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based... on 2009-06-02. The reason FDA records is "Product programmed with unapproved software was distributed". 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-3091-2011
Status: Terminated
Initiated: 2009-06-02
Posted: 2011-08-30
Terminated: 2012-09-27
Recalling firm: Abbott Medical
Product: Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Product programmed with unapproved software was distributed.
Root cause tag: software
FDA root cause: Software change control
Action: St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken. All affected devices were returned to the firm as instructed.
Quantity in commerce: 14 units
Distribution: Distributed in New Hampshire and Puerto Rico.
Product codes and lots: Serial numbers: 101565, 101544, 101555, 101548, 101561, 101551, 101563, 101546, 101556, 101553, 101554, 101558, 101545, and 101566

Product code LGW

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)