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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Power Console System

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  Class 2 Device Recall Integrated Power Console System see related information
Date Initiated by Firm July 17, 2009
Date Posting Updated November 13, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0259-2010
Recall Event ID 53603
510(K)Number K002828  
Product Classification ENT Surgical Drill including Handpiece - Product Code ERL
Product Medtronic Integrated Power Console System, IP X1

REF 1898001 or REF EC300

Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA.

Distributed by: Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137 USA.

No difference between two referenced Consoles (REF numbers differ for internal sales tracking purposes).
Code Information Serial Numbers International Distribution: 51033, 51106, 51107, 51120, 51121, 51122, 51123, 51124, 51128, 51135, 51157, 51167, 51169, 51174, 51175, 51176, 51177, 51178, 51182, 51183, 51184, 51185, 51217, 51220, 51291, 51308, 51334, 51344, 51349, 51350, 51356, 51378, 51388, 51439, 51508, 51635, 71002, 71037, 71041, 71045, 71082, 71170, 71198, 71206, 71247, 71270, 71280, 71298, 71303, 71324, 71335, 71336, 71337, 71339, 71340, 71341, 71345, 71347, 71349, 71350, 71356, 71357, 71358, 71360, 71361, 71368, 71375, 71381, 71387, 71388, 71431, 71432, 71433, 71434, 71435, 71437, 71438, 71439, 71440, 71441, 71454, 71455, 71456, 71457, 71468, 71472, 71494, 71495, 71507, 71508, 71509, 71517, 71519, 71520, 71521, 71532, 71533, 71534, 71545

Serial Numbers Domestic Distribution:, 51003, 51009, 51010, 51011, 51012, 51013, 51014, 51015, 51016, 51018, 51024, 51027, 51030, 51031, 51035, 51040, 51041, 51042, 51046, 51051, 51052, 51057, 51058, 51062, 51064, 51066, 51067, 51068, 51069, 51070, 51071, 51072, 51073, 51074, 51075, 51076, 51079, 51080, 51081, 51082, 51084, 51085, 51086, 51087, 51089, 51104, 51108, 51115, 51125, 51126, 51129, 51131, 51151, 51152, 51153, 51154, 51164, 51203, 51207, 51208, 51209, 51210, 51211, 51212, 51215, 51216, 51218, 51219, 51221, 51222, 51223, 51224, 51225, 51226, 51227, 51228, 51229, 51230, 51231, 51232, 51233, 51234, 51274, 51276, 51278, 51279, 51280, 51281, 51282, 51284, 51285, 51286, 51287, 51288, 51290, 51292, 51293, 51294, 51296, 51297, 51298, 51299, 51300, 51309, 51315, 51317, 51319, 51321, 51323, 51324, 51326, 51333, 51336, 51341, 51342, 51348, 51354, 51358, 51375, 51376, 51379, 51380, 51383, 51384, 51385, 51386, 51387, 51399, 51400, 51402, 51403, 51404, 51407, 51418, 51422, 51425, 51428, 51429, 51430, 51431, 51432, 51433, 51434, 51435, 51438, 51440, 51441, 51443, 51445, 51446, 51452, 51453, 51454, 51465, 51466, 51467, 51468, 51469, 51470, 51471, 51472, 51473, 51474, 51475, 51476, 51477, 51478, 51481, 51482, 51486, 51487, 51488, 51489, 51491, 51492, 51493, 51494, 51495, 51496, 51497, 51498, 51499, 51504, 51507, 51513, 51515, 51516, 51517, 51518, 51518, 51519, 51520, 51521, 51522, 51523, 51524, 51529, 51530, 51531, 51534, 51535, 51536, 51537, 51544, 51545, 51546, 51550, 51551, 51567, 51570, 51573, 51576, 51577, 51578, 51580, 51581, 51583, 51586, 51587, 51589, 51591, 51592, 51593, 51594, 51596, 51597, 51600, 51601, 51604, 51605, 51606, 51608, 51609, 51610, 51610, 51611, 51612, 51614, 51615, 51618, 51619, 51622, 51623, 51625, 51628, 51629, 51630, 51631, 51632, 51633, 51636, 51637, 51640, 51641, 51642, 51645, 51646, 71033, 71048, 71049, 71100, 71108, 71133, 71136, 71138, 71143, 71148, 71150, 71156, 71161, 71169, 71222, 71229, 71239, 71265, 71268, 71269, 71272, 71274, 71277, 71281, 71283, 71285, 71286, 71295, 71306, 71307, 71312, 71315, 71318, 71334, 71342, 71343, 71344, 71348, 71352, 71353, 71359, 71364, 71369, 71374, 71376, 71377, 71382, 71383, 71384, 71385, 71386, 71390, 71392, 71394, 71395, 71399, 71400, 71401, 71402, 71404, 71406, 71407, 71408, 71409, 71410, 71411, 71412, 71416, 71417, 71418, 71419, 71420, 71421, 71423, 71424, 71426, 71427, 71428, 71429, 71430, 71444, 71445, 71446, 71448, 71449, 71460, 71461, 71464, 71465, 71466, 71467, 71469, 71470, 71473, 71474, 71475, 71476, 71477, 71478, 71479, 71480, 71481, 71482, 71483, 71485, 71486, 71488, 71490, 71492, 71493, 71499, 71500, 71503, 71504, 71506, 71510, 71522, 71523, 71524, 71525, 71527, 71528, 71529, 71530, 71542, 71543, 71544, 71546, 71547, 71549, 71550, 71551, 71553, 71554, 71555, 71558, 71559, and , 71573.

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Recalling Firm/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact
904-296-9600
Manufacturer Reason
for Recall
An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.
FDA Determined
Cause 2
Software design
Action A Product Correction Notification was issued to each consignee on June 15, 2009. Medtronic sales representatives will visit each facility to advise consignees of the issue and to install a software upgrade that will correct the handpiece recognition issue on the console(s).
Quantity in Commerce 493
Distribution Worldwide Distribution
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.
510(K) Database 510(K)s with Product Code = ERL and Original Applicant = XOMED, INC.
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