O-arm O2 Imaging System. Mobile X-Ray System.
FDA device recall Z-2101-2025 · posted 2025-07-09 · Open, Classified
Recall details
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Reason for recall
- A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 3 units
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
- Date initiated
- 2025-05-27
- Date posted
- 2025-07-09
- Location
- Boxborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-arm O2 Imaging System (K240465) | Medtronic Navigation, Inc. | 2024-06-21 |