Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The
FDA device recall Z-1849-2012 · posted 2012-06-21 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Software Version 3.1.1 does not meet navigational accuracy.
- Action taken
- Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 3 units
- Distribution
- Nationwide Distribution including the states of CO, IN, and MN.
- Date initiated
- 2010-10-12
- Date posted
- 2012-06-21
- Date terminated
- 2012-06-21
- 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 |