Medtronic Navigation, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1849-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 12, 2010

Date Posted: June 27, 2012

Recall Number: Z-1849-2012

Event ID: 61741

Reason for Recall:

Software Version 3.1.1 does not meet navigational accuracy.

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial Numbers: 125, 156, 234R.

Distribution Pattern:

Nationwide Distribution including the states of CO, IN, and MN.

Voluntary or Mandated:

Voluntary: Firm initiated