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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/
Manufacturer		 Advanced Bionics Corp
12740 San Fernando Rd
Sylmar CA 91342
For Additional Information Contact Kaoru Lee Adair
661-362-1669
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		 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
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.
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