Medtronic Navigation, Inc.-Littleton: Medical Device Recall in 2016 - (Recall #: Z-0070-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions

Product Classification:

Class II

Date Initiated: September 22, 2016

Date Posted: October 19, 2016

Recall Number: Z-0070-2017

Event ID: 75279

Reason for Recall:

O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images

Status: Terminated

Product Quantity: 14 units

Code Information:

Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930 C0981 C0986 C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated