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U.S. Department of Health and Human Services

Class 3 Device Recall Precision Spinal Cord Stimulation System

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  Class 3 Device Recall Precision Spinal Cord Stimulation System see related information
Date Initiated by Firm January 30, 2007
Date Posted March 31, 2007
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-0700-2007
Recall Event ID 37462
PMA Number P030017 
Product Classification Implantable Pulse Generator, - Product Code LGW
Product The Precision Implantable Pulse Generator, Model Number SC-1110
Code Information 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
Recalling Firm/
Advanced Bionics Corp
12740 San Fernando Rd
Sylmar CA 91342
For Additional Information Contact Kaoru Lee Adair
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = Boston Scientific Corp.