FDAFDA · Alimentos y medicamentos·N.º oficial Z-1272-2021
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.
Publicado el 24 de marzo de 2021 · Inicio del retiro: 26 de febrero de 2021
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Accuray Incorporated
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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