Class 2 Device Recall CyberKnife Robotic Radiosurgery Systems

• Date Initiated by Firm: December 06, 2016
• Date Posted: December 21, 2016
• Recall Status: Terminated on June 09, 2017
• Recall Number: Z-0865-2017
• Recall Event ID: 75891
• 510(K)Number: K011024
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.; ; Radiology: The CyberKnife Robotic Radiosurgery System is 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.
• Code Information: models: G3, G4, VSI. Serial numbers: C0023 C0030 C0045 C0046 C0047 C0006 C0012 C0040 C0048 C0049 C0013 C0011 C0052 C0055 C0022 C0053 C0042 C0057 C0017 C0059 C0056 C0060 C0062 C0061 C0067 C0068 C0070 C0041 C0063 C0065 C0074 C0071 C0079 C0078 C0080 C0064 C0090 C0024 C0087 C0091 C0095 C0094 C0092 C0093 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0089 C0108 C0107 C0105 C0112 C0114 C0118 C0119 C0113 C0123 C0126 C0124 C0121 C0132 C0130 C0131 C0125 C0133 C0135 C0117 C0134 C0038 C0136 C0137 C0127 C0143 C0144 C0014 C0138 C0146 C0140 C0145 C0150 C0033 C0151 C0152 C0147 C0149 C0148 C0158 C0155 C0159 C0007 C0163 C0157 C0165 C0008 C0162 C0085 C0161 C0086 C0073 C0115 C0076 C0153 C0077 C0111 C0066 C0027 C0075 C0084 C0096 C0154.
• Recalling Firm/ Manufacturer: Accuray Incorporated; 1310 Chesapeake Ter; Sunnyvale CA 94089-1100
• For Additional Information Contact: Tony Roder; 608-824-3362
• Manufacturer Reason for Recall: Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
• FDA Determined Cause: Device Design
• Action: Accuray Incorporated sent an Urgent Safety Advisory Notification letter to all affected customers on December 1, 2016 by traceable method.. Letters identified the product, the problem, and the action to be taken by the customer. provided users with affected product and described the issue. The final resolution will result in a modulator cabinet inspection and installation of the Plexiglas cover - as necessary. Customers will be contacted by Accuray to schedule the inspection. Prior to this modulator cabinet inspection, inform all applicable personnel of the potential danger and need to closely follow electrical safety procedures. Customers with questions were instructed to contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Tehnical Solution Center at http://www.accuray.com/services-support or call: North America +1-877-666-8667, Europe +800-4141-9595, Hong Kong +852-2247-8688, Japan +81-3-6265-1530. Customers were also asked to complete the attached acknowledgement and return to Accuracy. For questions regarding this recall call 608-824-3362.
• Quantity in Commerce: 115 affected devices.
• Distribution: Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = ACCURAY, INC.