FDA Enforcement
Class II
Ongoing
O-arm O2 Imaging System. Mobile X-Ray System.
Recall: Z-2101-2025
·
Reported July 16, 2025
Enforcement
- Recall Number
- Z-2101-2025
- Event ID
- 97045
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.-Boxborough
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 16, 2025
- Initiation Date
- May 27, 2025
- Classification Date
- July 9, 2025
- Address
- 200 Beaver Brook Road, N/A, Boxborough, MA, 01719, United States
Description
O-arm O2 Imaging System. Mobile X-Ray System.
Reason
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Code Info
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Distribution
US Nationwide distribution in the states of IN, MN, MS.
Quantity
3 units