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Terminated

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

FDA Recall Z-0070-2017 · Posted 2016-10-11

Recalling FirmMedtronic Navigation, Inc.-Littleton
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-09-22
Date Terminated2017-05-12
Product Quantity14 units

Reason for Recall

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

Firm Action

Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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