O-arm O2 Imaging System. Mobile X-Ray System.
This recall is currently active, issued July 9, 2025. It was issued by Medtronic Navigation, Inc.-Boxborough.
- Recall Initiated
- May 27, 2025
- Posted
- July 9, 2025
- Recall Number
- Z-2101-2025
- Quantity
- 3 units
- Firm Location
- Boxborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Root Cause
Under Investigation by firm
Action Taken
An URGENT: MEDICAL DEVICE CORRECTION notice dated 5/27/25 was mailed to consignees. In the notice consignees are instructed to discontinue use of affected systems until it can be serviced by Medtronic personnel; a copy of the recall notification is to be posted with the system until the issue has been resolved. A Medtronic Field Service Engineer will contact consignees to schedule a visit to inspect affected systems and implement any corrections needed. Consignees are to complete and return the provided Customer Confirmation Form and forward the recall notification to all users and facilities to which product was further distributed. Consignees with any questions can contact Technical Services for help by phone at 1-888-826-5603 or by email at rs.navtechsupport@medtronic.com.