Accuray Incorporated recalls CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided s…

Recall date

September 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0408-2019

FDA classification

Class II

Brand / firm

Accuray Incorporated

Sold / distributed

worldwide distribution.

Why it was recalled

A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.