Boxborough, MA, United States
Medtronic Navigation, Inc.-Boxborough recalls
2 recalls recorded since 2018, most recently on 19 May 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Ir
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2451-2026
- Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Ongoing Class II Medical devices
- Recall started
- 27 May 2025
- Reason
- A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2101-2025
- O-arm O2 Imaging System. Mobile X-Ray System.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.