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

Recall details

Manufacturer

Medtronic Xomed, Inc.

Distributor

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.

Lot

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

Risk classification

Class I

Area (FDA)

device

Country

United States