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Accuray Incorporated recalls CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guide
Recalled November 14, 2018 · FDA recall Z-0408-2019 · Accuray Incorporated
Hazard
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. · FDA Class II
Units
93 units
Sold at
worldwide distribution.
Description
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.
Product
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.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →