Recalls / —
—#108856
Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
- FDA product code
- IZL — System, X-Ray, Mobile
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K092564
- Affected lot / code info
- Serial Numbers: 125, 156, 234R.
Why it was recalled
Software Version 3.1.1 does not meet navigational accuracy.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Navigation, Inc.
- Address
- 300 Foster St, Littleton, Massachusetts 01460-2017
Distribution
- Distribution pattern
- Nationwide Distribution including the states of CO, IN, and MN.
Timeline
- Recall initiated
- 2010-10-12
- Posted by FDA
- 2012-06-21
- Terminated
- 2012-06-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #108856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.