Recall Z-0408-2019 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
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.
| Date | Sep 26, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | The firm, KUKA, issued a Field Safety Notice dated 9/13/2018 and disseminated it beginning on 09/26/2018 by mail, email, and hand delivery. The Field Safety Notice explained the issues and stated that all units would be inspected. Should a unit be faulty, the firm will arrange for remediation. If you have any technical questions, please feel free to get in touch with KUKA Account Manager or contact our hotline via phone 1-800-459-6691 or email: FocusCenter@Kuka.com. |
| Quantity | 93 units |
| Distribution | worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System Accuray Incorporated, Jul 1, 2015 |