Medtronic (NYSE:MDT) announced that it determined that a replacement of the internal gantry tractor motor drive will resolve an issue with the O-arm O2 imaging system that the company warned customers of last year.
In November, Medtronic notified customers of the potential for navigational inaccuracy with the O-arm O2 system’s auto-registration feature when used in conjunction with an image-guided surgery system.
The navigational inaccuracy could occur due to the potential for loosening of the drive belt, which the medtech giant believes it has remedied with the replacement of the internal O-arm gantry tractor motor drive, according to the safety notice.
Medtronic’s O-arm O2 imaging system is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for anatomic structures and objects with high x-ray attenuation, such as bony anatomy and metallic objects. The company determined that, if the gantry tractor motor drive belt loosens after an extended number of uses, it can result in the rotation of 3D images about the gantry isocenter.
Despite anatomical accuracy within the 3D image itself, the electronic registered location may be rotated if the issue occurs, which can lead to the inaccuracy of navigated positions that may or may not be detected and could result in serious injury.
Medtronic said that, since it sent the November letter to users, it received one complaint due to the issue. The complaint did not lead to patient injury, and the company stressed that instructions within the O-arm O2 system user manual help with the identification of the issue if it occurs.
The company said its local Medtronic service representatives will begin scheduling system service visits as soon as possible, and it 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.