Medtronic Navigation, Inc.-Littleton: Device Recall
Recall #Z-2026-2024 · 04/26/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2026-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medtronic Navigation, Inc.-Littleton
- Status
- Ongoing
- Date Initiated
- 04/26/2024
- Location
- Littleton, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Reason for Recall
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Product Description
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.