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).
FDA Recall Z-0259-2010 · Posted 2009-11-13
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Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeERL
Date Initiated2009-07-17
Date Terminated2010-01-20
Product Quantity493
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.
Firm 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).
Root Cause
Software design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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