Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA device recall Z-0926-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
- Action taken
- Medtronic Navigation issued a Field Safety Notice letter dated January 18, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter instructed customers not to discontinue use and that a Medtronic Navigation Representative will be contacting them shortly to schedule a time to conduct the motion control box upgrade. For questions contact your local Medtronic Navigation representative or call Technical Services Group at 800-595-9709 or (720) 890-3200, or email at rs.navtechsupport@ medtronic.com.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 463 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAN
- Date initiated
- 2013-01-31
- Date posted
- 2013-03-08
- Date terminated
- 2016-07-06
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K092564) | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 |