Medtronic Navigation, Inc.-Littleton: Medical Device Recall in 2023 - (Recall #: Z-2449-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 25, 2023

Date Posted: August 30, 2023

Recall Number: Z-2449-2023

Event ID: 92778

Reason for Recall:

Ground cable installed incorrectly.

Status: Ongoing

Product Quantity: 28 units

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated