Medtronic O-arm Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120
FDA device recall Z-2244-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.
- Action taken
- Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm Imaging System.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
- Date initiated
- 2012-07-11
- Date posted
- 2012-08-22
- Date terminated
- 2016-06-06
- Location
- Littleton, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K092564) | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 |