FDAHealthMay 27, 2025
Medtronic Navigation, Inc.-Boxborough — O-arm O2 Imaging System. Mobile X-Ray System.
⚠️ A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 27, 2025
US Nationwide distribution in the states of IN, MN, MS.
What's affected?
- Product
- O-arm O2 Imaging System. Mobile X-Ray System.
- Lot code
- CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Additional details
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.
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