Recall of Device Recall Precision Spinal Cord Stimulation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Bionics Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable Pulse Generator, - Product Code LGW
  • Reason
    The precision implantable pulse generator with firmware revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
  • Action
    March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.


  • Model / Serial
    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 Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide including Puerto Rico
  • Product Description
    The Precision Implantable Pulse Generator, Model Number SC-1110
  • Manufacturer


  • Manufacturer Address
    Advanced Bionics Corp, 12740 San Fernando Rd, Sylmar CA 91342
  • Source