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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Accuray Incorporated
Lot Codes / Batch Numbers
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
Products Sold
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
Accuray Incorporated is recalling CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radios due to The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026