Recall Z-1272-2021 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | Feb 26, 2021 |
| Status | Terminated |
| Reason | The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. |
| Root cause | Equipment maintenance |
| Action | An URGENT FIELD SAFETY NOTICE will be delivered to customers beginning on 02/26/2021. Customers are asked to return a signed copy of the letter back to Accuray. Field Service Engineers will visit all impacted sites to perform a work instruction that includes the inspection of the set screws and verification of the integrity of the overall couch system, including the linkage arm and its connection to the roll motor. This work instruction will be performed on an annual basis. Customers may continue to use the STC and CyberKnife System. However, those who assist patients should provide extra care |
| Quantity | 243 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AZ. CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV, PR and the countries of Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170788 | CyberKnife Treatment Delivery System Accuray Incorportaed, Apr 11, 2017 |