Recall Z-0259-2010 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Medtronic Xomed, Inc.
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).
| Date | Nov 13, 2009 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 493 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002828 | XPS NITRO SYSTEM Xomed, Inc., Oct 17, 2000 |