Recall Z-2101-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Boxborough
O-arm O2 Imaging System. Mobile X-Ray System.
| Date | Jul 9, 2025 (initiated May 27, 2025) |
| Status | Open, Classified |
| Reason | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of IN, MN, MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240465 | O-arm O2 Imaging System Medtronic Navigation, Inc., Jun 21, 2024 |