O-arm O2 (X-ray system)

2020: Warning of defects

At the end of January, 2020 Medtronic issued the express notice about security concerning X-ray system for surgeons of O-arm O2. The company warns about defects of software of a system of visualization: "the inaccuracy of navigation" when using function of automatic registration of a system can be noted, "when it is applied to visual control".

Weakening of a drive belt became the reason of a problem. The producer claims that replacement of the internal O-arm drive will solve a problem. It is known that the company received only one complaint, the situation was resolved without prejudice to the patient.

The company warns about defects of software of a system

Medtronic found out that weakening of a drive belt for an appreciable length of time can bring to turn of three-dimensional images around the isocenter of a gentra. "Though the three-dimensional image is anatomic exact and can be used for therapy control, the picture can be turned rather actual position of the patient".

The company stated that her representatives on places already began unplanned office service of the rejected systems to fix problems. The diagram of visits is formed depending on use term X-ray system and also availability of the replaced components. The problem concerns only several O-arm O2 devices with certain serial numbers which owners were already warned about possible deviations.

According to the company, the O-arm O2 system "represents the mobile x-ray system intended for 2D - roentgenoscopy and 3D - visualization and held for use when the doctor can use information on the anatomical structures and objects weakening X-rays such as skeleton and metal objects".^[1]

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