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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accuray Incorporated
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot 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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1272-2021
Related Recalls
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Accuray Incorporated
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.