O-arm O2 Imaging System. Mobile X-Ray System.
Class I - Dangerous 🏥 Medical Devices
Recalled: May 27, 2025 Medtronic Navigation, Inc.-Boxborough Diagnostic Equipment
Nationwide
What Should You Do?
- Check if you have this product: CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
O-arm O2 Imaging System. Mobile X-Ray System.
Product Codes/Lot Numbers:
CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2101-2025