Device 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.
Z-1849-2012
Product summary
- Event
- Event 61741
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1849-2012
Official wording
Reason: Software Version 3.1.1 does not meet navigational accuracy.
Code information: Serial Numbers: 125, 156, 234R.
Distribution pattern: Nationwide Distribution including the states of CO, IN, and MN.
Derived failure modes
-
Unknown
Software Version 3.1.1 does not meet navigational accuracy.