Medtronic Navigation, Inc.-Boxborough: Device Recall
Recall #Z-2101-2025 · 05/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2101-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medtronic Navigation, Inc.-Boxborough
- Status
- Ongoing
- Date Initiated
- 05/27/2025
- Location
- Boxborough, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Reason for Recall
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Product Description
O-arm O2 Imaging System. Mobile X-Ray System.
Distribution Pattern
US Nationwide distribution in the states of IN, MN, MS.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.