Z-0700-2007

The Precision Implantable Pulse Generator, Model Number SC-1110

Name: Z-0700-2007 The Precision Implantable Pulse Generator, Model Number SC-1110
Creator: Advanced Bionics Corp
Published: 2007-01-30
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2007-01-30 / Terminated / root cause: software

FDA source

Advanced Bionics Corp began a recall of The Precision Implantable Pulse Generator, Model Number SC-1110 on 2007-01-30. The reason FDA records is "The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check". 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-0700-2007
Status: Terminated
Initiated: 2007-01-30
Posted: 2007-03-31
Terminated: 2012-01-25
Recalling firm: Advanced Bionics LLC
Product: The Precision Implantable Pulse Generator, Model Number SC-1110
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
Root cause tag: software
FDA root cause: Other
Action: March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.
Quantity in commerce: 5 unimplanted devices; 52 implanted devices
Distribution: Nationwide including Puerto Rico
Product codes and lots: 161773, 161898, 161934, 161969, 160753,102331,103463,103497,103525,160041,160077, 160080,160088,160090,160091,160092,16009,160096, 160103,160104,160105,160107,160108,160110,160113, 160115,160141,160142,160144,160146,160602,161028, 161065,161222,161350,161415,161425,161430,161457, 161484,161497,161508,161579,161644,161658,161674, 161680,161681,161700,161751,161760,161790,161807, 161840,161853,810024,810051

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