O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Brand
Medtronic Navigation, Inc.-Boxborough
Lot Codes / Batch Numbers
CFN: BI70002000, UDI: 00763000709631, Serial No. C4014, C4017, C4019.
Products Sold
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Medtronic Navigation, Inc.-Boxborough is recalling O-arm O2 Imaging System. Mobile X-Ray System. due to A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026