O-arm O2 Imaging System. Mobile X-Ray System recall
O-arm O2 Imaging System. Mobile X-Ray System.
Why was O-arm O2 Imaging System. Mobile X-Ray System recalled?
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
- Product
- O-arm O2 Imaging System. Mobile X-Ray System.
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of IN, MN, MS.
- Recall date
- July 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)