Medtronic Navigation, Inc.-Littleton Recall 92778
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.
Medtronic Navigation, Inc.-Littleton Recall 92778 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2449-2023 |
| Event ID | 92778 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam. |
| Quantity | 28 units |
| Recall Reason | Ground cable installed incorrectly. |
| Device Classification | 20230830 |
| Device Code Info | Model No. BI70002000; UDI-DI: 00763000074128, 00763000081041, 00763000355555, 00763000496784, 00763000542801, 00763000616434, 00763000616526, 00763000616564; Serial No. C2786, C2841, C2781, C2624, C2659, C2660, C2665, C2672, C2708, C2723, C2735, C2760, C2774, C2775, C2779, C2798, C2814, C2823, C2873, C2918, C2968, C3290, C3363, C3188, C3322, C3387, C3404, and C3418. |
| Center Classification Date | 20230824 |
| Recall Initiation Date | 20230725 |
| Recalling Firm | Medtronic Navigation, Inc.-Littleton |
| Initial Notification | Letter |
| Similar To |