Z-0070-2017Class II

Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000

Name: Z-0070-2017 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2016-09-22
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-09-22 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a... on 2016-09-22. FDA classified it as Class II and gives the reason as "O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0070-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-22
Posted: 2016-10-11
Terminated: 2017-05-12
Recalling firm: Medtronic Navigation, Inc
Product: 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 code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-11

Product code OWB

K151000Class IIO-Arm O2 Imaging SystemMedtronic, Inc. / cleared 2015-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)