Medtronic Navigation, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1088-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging 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. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

Product Classification:

Class II

Date Initiated: January 29, 2016

Date Posted: March 16, 2016

Recall Number: Z-1088-2016

Event ID: 73303

Reason for Recall:

Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: C0936

Distribution Pattern:

Worldwide Distribution to Austria only.

Voluntary or Mandated:

Voluntary: Firm initiated