Recall Z-0408-2019— Accuray Incorporated
Class II · Terminated
Class II FDA medical device recall by Accuray Incorporated, initiated 2018-09-26, terminated 2021-05-12. It names one FDA 510(k) clearance: K150873. 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.. Reason: 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..
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-26
- Terminated
- 2021-05-12
- Firm location
- Madison, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.