FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.-Littleton: 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
- Recall number
- Z-0070-2017
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- 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
- Status
- Terminated
- Initiated
- 2016-09-22
- Posted
- 2016-10-11
- Terminated
- 2017-05-12
- Reason
- O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
- 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
- 14 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K151000"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3004785967
- Firm city
- Littleton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28