O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Reported: June 12, 2024 Initiated: April 26, 2024 #Z-2026-2024
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
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.-Littleton
- Units Affected
- 20 units
- Distribution
- 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.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000. Recalled by Medtronic Navigation, Inc.-Littleton. Units affected: 20 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-2026-2024.
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