Recall Z-2026-2024— Medtronic Navigation, Inc.-Littleton
Class II · Ongoing
Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2024-04-26. It names one FDA 510(k) clearance: K151000. Product: 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: 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..
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-26
- Firm location
- Littleton, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.