Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
- Recall date
- May 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2101-2025
- FDA classification
- Class II
- Brand / firm
- Medtronic Navigation, Inc.-Boxborough
- Sold / distributed
- US Nationwide distribution in the states of IN, MN, MS.
Why it was recalled
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
O-arm O2 Imaging System. Mobile X-Ray System.
Get recall alerts
Free email alert whenever Medtronic Navigation, Inc.-Boxborough has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Medtronic Navigation, Inc.-Boxborough