Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive N
FDA device recall Z-0259-2010 · posted 2009-11-13 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- ERL
- Quantity affected
- 493
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-17
- Date posted
- 2009-11-13
- Date terminated
- 2010-01-20
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPS NITRO SYSTEM (K002828) | Xomed, Inc. | 2000-10-17 |