O-arm O2 Imaging System. Mobile X-Ray System recallZ-2101-2025 · Medtronic Navigation, Inc.-Boxborough · initiated May 27, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc.-Boxborough or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2101-2025
- Status
- Open, Classified
- Initiated by the company
- May 27, 2025
- Posted by the FDA
- Jul 9, 2025
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Quantity
- 3 units
- Product code
- OWB
- FDA submissions
- K240465
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
Product description
O-arm O2 Imaging System. Mobile X-Ray System.
Code information (models, lots, serial numbers)
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- O-armTM O2 Imaging System BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile2 recalls1 death72 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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