In November 2019, Medtronic issued an urgent field safety notice regarding its O-arm O2 Imaging System.
The company said there was a “potential for navigational inaccuracy” when using the system’s auto-registration feature, “when used in conjunction with an Image-Guided Surgery System, for a specific set of O-arm O2 Imaging System serial numbers.”
The cause of the problem was the loosening of a drive belt. The company assured users that a replacement of the internal O-arm gantry tractor motor drive will resolve the issue.
Since issuing the notice, the company has only received one complaint with no injury to a patient.
According to the notice, the navigational inaccuracy occurred when the O-arm registration information was transferred to an Image-Guided Surgery System to be used in navigation, utilizing rotated images.
The company determined that when the gantry tractor motor drive belt loosened over an extended number of uses, it could result in rotation of 3D images about the gantry isocenter. “While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.”
This rotation could lead to “potentially significant navigational inaccuracies” that may or may not be detected through direct observation.
The company said its local service reps began scheduling system service visits as soon as possible and expects the servicing to be conducted over the next nine months. Scheduling is slated to be based on system age as well as replacement component availability.
The O-arm O2 system, according to the company, “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.”
You can read the safety notice here.
