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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2409-2024

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143

Publicado el 31 de julio de 2024 · Inicio del retiro: 24 de junio de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential for false negative response on the NIM Vital Nerve Monitoring System

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Xomed, Inc.
Distribuidor
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
Lote
All serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. Product Number; GTIN Number (Lot Number): 1. Product Number: NIM4CM01; GTIN Number (Lot Number): 00763000002978 (1850076, 1850079, 1850082, 1850083, 1850093, 1850095, C1915008, C1915009, C1915012, C1915013, C1915014, C1915015, C1915018, C1915020, C1915022, C1915025, C1915027, C1915028, C1915030, C1915031, C1915032, C1915038, C1915039, C1915040, C1915042, C1915048, C1915053, C1915057, C1915061, C1915062, C1915063, C1915064, C1915065, C1915066, C1915068, C1915069, C1915070, C1915072, C1915073, C1915074, C1915075, C1915077, C1915080, C1915085, C1915089, C1915090, C1915094, C1915096, C1915098, C1915102, C1915103, C1915104, C1915105, C1915106, C1915107, C1915108, C1915109, C1915110, C1915116, C1915119, C1915121, C1915124, C1915127, C1915129, C1915130, C1915131, C1915152, C1915153, C1915157, C1915158, C1915160, C1915161, C1915165, C1915166, C1915168, C1915175, C1915176, C1915177, C1915179, C1915180, C1915183, C1915184, C1915185, C1915186, C1915188, C1915215, C1915216), 00763000395896 (C2026001, C2026004, C2026006, C2026008, C2026010, C2026011, C2026014, C2026016, C2026017, C2026018, C2026019, C2026020, C2026022, C2026023, C2026024, C2026025, C2026026, C2026027, C2026030, C2026031, C2026032, C2026033, C2026034, C2026035, C2026036, C2026037, C2026038, C2026039, C2026040, C2026041, C2026042, C2026043, C2026044, C2026045, C2026048, C2026049, C2026050, C2026053, C2026054, C2026055, C2026056, C2026057, C2026059, C2026060, C2026061, C2026063, C2026067, C2026068, C2026069, C2026070, C2026071, C2026072, C2026073, C2026074, C2026075, C2026110, C2026111, C2026112, C2026113, C2026134, C2026136, C2026137, C2026139, C2026140, C2026141, C2026142, C2026143, C2026144, C2026145, C2026146, C2026147, C2026151, C2026154, C2026155, C2026157, C2026159, C2026160, C2026167, C2026168, C2026169, C2026170, C2026171, C2026172, C2026173, C2026175, C2026181, C2026183, C2026185, C2026189, C2026192, C2026193, C2026196, C2026197, C2026198, C2026199, C2026200, C2026201, C2026202, C2026203, C2026204, C2026205, C2026206, C2026207, C2026210, C2026211, C2026212, C2026214, C2026215, C2026216, C2026217, C2026219, C2026220, C2026221, C2026222, C2026223, C2026225, C2026226, C2026227, C2026228, C2026229, C2026230, C2026231, C2026232, C2026233, C2026234, C2026235, C2026236, C2026237, C2026238, C2026239, C2026240, C2026241, C2026243, C2026244, C2026245, C2026248, C2026249, C2026250, C2026251, C2026252, C2026253, C2026254, C2026255, C2026256, C2026257, C2026258, C2026259, C2026260, C2026261, C2026262, C2026263, C2026264, C2026265, C2026267, C2026268, C2026270, C2026271, C2026272, C2026275, C2026276, C2026278, C2026279, C2026280, C2026281, C2026283, C2026284, C2026285, C2026287, C2026288, C2026289, C2026291, C2026292, C2026294, C2026295, C2026296, C2026297, C2026301, C2026302, C2026307, C2026308, C2026309, C2026310, C2026311, C2026312, C2026314, C2026315, C2026318, C2026319, C2026320, C2026321, C2026322, C2026323, C2026324, C2026325, C2026326, C2026327, C2026328, C2026329, C2026332, C2026334, C2026335, C2026336, C2026337, C2026338, C2026340, C2026341, C2026342, C2026343, C2026344, C2026345, C2026348, C2026349, C2026351, C2026352, C2026353, C2026354, C2026355, C2026356, C2026357, C2026358, C2026359, C2026360, C2026361, C2026363, C2026364, C2026365, C2026366, C2026367, C2026368, C2026369, C2026370, C2026371, C2026373, C2026374, C2026376, C2026377, C2026378, C2026379, C2026380, C2026382, C2026383, C2026384, C2026385, C2026386, C2026387, C2026388, C2026389, C2026390, C2026391, C2026392, C2026393, C2026394, C2026395, C2026397, C2026398, C2026399, C2026400, C2026403, C2026404, C2026405, C2026406, C2026407, C2026408, C2026409, C2026410, C2026411, C2026412, C2026413, C2026414, C2026415, C2026416, C2026417, C2026418, C2026419, C2026420, C2026421, C2026423, C2026424, C2026426, C2026429, C2026430, C2026431, C2026433, C2026434, C2026435, C2026436, C2026437, C2026438, C2026439, C2026440, C20264
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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