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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid Programmer

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  Class 2 Device Recall Rapid Programmer see related information
Date Initiated by Firm June 02, 2009
Date Posted August 30, 2011
Recall Status1 Terminated 3 on September 27, 2012
Recall Number Z-3091-2011
Recall Event ID 57806
PMA Number P010032 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
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.
Code Information Serial numbers: 101565, 101544, 101555, 101548, 101561, 101551, 101563, 101546, 101556, 101553, 101554, 101558, 101545, and 101566
Recalling Firm/
Advanced Neuromodulation Systems
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact
Manufacturer Reason
for Recall
Product programmed with unapproved software was distributed.
FDA Determined
Cause 2
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.
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 = Abbott Medical