Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R an...
FDA Recall #Z-1849-2012 — Class II — October 12, 2010
Product Description
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.
Reason for Recall
Software Version 3.1.1 does not meet navigational accuracy.
Recalling Firm
Medtronic Navigation, Inc. — Littleton, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
Nationwide Distribution including the states of CO, IN, and MN.
Code Information
Serial Numbers: 125, 156, 234R.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated