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.
This recall has been terminated (originally issued February 26, 2021).
- Company
- Accuray Incorporated
- Recall Initiated
- February 26, 2021
- Terminated
- June 27, 2022
- Recall Number
- Z-1272-2021
- Quantity
- 243 units
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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
Root Cause
Equipment maintenance
Action Taken
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.