Recall Z-2449-2023— Medtronic Navigation, Inc.-Littleton
Class II · Ongoing
Class II FDA medical device recall by Medtronic Navigation, Inc.-Littleton, initiated 2023-07-25. It names one FDA 510(k) clearance: K151000. Product: The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.. Reason: Ground cable installed incorrectly..
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-25
- 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
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Reason for recall
Ground cable installed incorrectly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.