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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Treatment Delivery System

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  Class 2 Device Recall CyberKnife Treatment Delivery System see related information
Date Initiated by Firm February 26, 2021
Create Date March 17, 2021
Recall Status1 Terminated 3 on June 27, 2022
Recall Number Z-1272-2021
Recall Event ID 87439
510(K)Number K170788  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information Product Codes: 019200, 020600, 021831, 022986, 023730, 025000, 027600, 028000, 030000, 031000, 031500, 0660000, 029640-001, 029828-003, 031000-004, 032000-001, 032000-004, 033000-000, 033000-010, 053101-010, 053101-M-000, 053301-010, 053301-M-000, 053401-010, 053401-M-000, 054000-002, 054000-004, 0660000-000, 1010140-000, 1047641-000 Serial Numbers: C0063, C0067, C0008, C0076, C0077, C0085, C0098, C0101, C0112, C0126, C0131, C0135, C0138, C0151, C0155, C0162, C0166, C0172, C0174, C0176, C0177, C0186, C0187, C0188, C0195, C0197, C0200, C0206, C0208, C0211, C0213, C0228, C0231, C0234, C0240, C0242, C0246, C0253, C0263, C0266, C0271, C0239, C0441, C0446, C0447, C0456, C0460, C0464, C0465, C0469, C0472, C0475, C0481, C0506, C0507, C0193, C0241, C0293, C0090, C0092, C0093, C0100, C0103, C0104, C0115, C0117, C0119, C0124, C0130, C0148, C0150, C0153, C0168, C0181, C0182, C0194, C0205, C0226, C0235, C0236, C0244, C0254, C0255, C0258, C0259, C0267, C0268, C0274, C0276, C0280, C0282, C0283, C0285, C0286, C0289, C0291, C0292, C0297, C0298, C0299, C0300, C0301, C0302, C0303, C0304, C0305, C0306, C0309, C0310, C0312, C0313, C0317, C0319, C0321, C0325, C0328, C0329, C0331, C0339, C0347, C0353, C0357, C0365, C0377, C0382, C0386, C0388, C0399, C0401, C0403, C0405, C0416, C0432, C0435, C0451, C0064, C0071, C0074, C0091, C0099, C0102, C0137, C0238, C0249, C0252, C0270, C0277, C0294, C0417, C0476, C0384, C0414, C0424, C0439, C0427, C0428, C0344, C0423, C0372, C0387, C0330, C0343, C0345, C0346, C0348, C0351, C0352, C0356, C0360, C0363, C0368, C0369, C0370, C0373, C0380, C0381, C0383, C0389, C0390, C0394, C0395, C0396, C0397, C0398, C0402, C0404, C0406, C0411, C0413, C0415, C0420, C0422, C0429, C0430, C0436, C0437, C0438, C0440, C0444, C0445, C0448, C0453, C0457, C0458, C0466, C0461, C0467, C0473, C0480, C0482, C0484, C0486, C0487, C0488, C0489, C0490, C0491, C0492, C0493, C0494, C0495, C0496, C0497, C0500, C0505, C0513, C0014, C0022, C0040, C0042, C0046, C0047, C0056, C0059, C0066, C0079, C0086, C0089, C0140, C0173, C0311, C0355, C0470
Recalling Firm/
Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact Daniel Biank
Manufacturer Reason
for Recall
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
FDA Determined
Cause 2
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 when individuals are getting on or off the STC.
Quantity in Commerce 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, Costa Rica, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Republic of Korea, Latvia, Luxembourg, Malaysia, Mexico, Oman, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
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 Incorportaed