Recall archive / FDA device enforcement

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, ... — FDA record Z-2409-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: Potential for false negative response on the NIM Vital Nerve Monitoring System
Classification: Class I
Recalling firm: Medtronic Xomed, Inc.
Quantity: 7,804 units
Agency-reported status: Ongoing
Source record identifier: Z-2409-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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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, C2026441, C2026443, C2026444, C2026445, C2026446, C2026447, C2026448, C2026449, C2026450, C2026451, C2026452, C2026453, C2026455, C2026456, C2026457, C2026458, C2026461, C2026462, C2026463, C2026464, C2026466, C2026467, C2026468, C2026469, C2026470, C2026471, C2026472, C2026473, C2026474, C2026476, C2026477, C2026478, C2026479, C2026480, C2026481, C2026482, C2026484, C2026485, C2026486, C2026487, C2026488, C2026490, C2026491, C2026492, C2026494, C2026496, C2026497, C2026498, C2026499, C2026500, C2110002, C2110003, C2110004, C2110005, C2110006, C2110007, C2110008, C2110011, C2110012, C2110013, C2110017, C2110022, C2110023, C2110024, C2110026, C2110028, C2110029, C2110030, C2110031, C2110032, C2110033, C2110035, C2110036, C2110037, C2110038, C2110041, C2110042, C2110043, C2110044, C2110045, C2110046, C2110047, C2110052, C2110053, C2110054, C2110055, C2110056, C2110057, C2110058, C2110059, C2110060, C2110061, C2110062, C2110063, C2110065, C2110067, C2110068, C2110069, C2110070, C2110071, C2110072, C2110073, C2110074, C2110075, C2110077, C2110078, C2110079, C2110080, C2110081, C2110082, C2110083, C2110084, C2110085, C2110087, C2110089, C2110090, C2110091, C2110092, C2110093, C2110094, C2110095, C2110099, C2110100, C2110101, C2110102, C2110103, C2110104, C2110105, C2110106, C2110107, C2110108, C2110109, C2110119, C2110120, C2110121, C2110123, C2110124, C2110125, C2110126, C2110127, C2110128, C2110129, C2110130, C2110131, C2110132, C2110135, C2110136, C2110137, C2110138, C2110139, C2110140, C2110141, C2110142, C2110143, C2110144, C2110145, C2110146, C2110147, C2110148, C2110149, C2110150, C2110151, C2110152, C2110153, C2110154, C2110155, C2110156, C2110158, C2110159, C2110161, C2110162, C2110163, C2110165, C2110166, C2110167, C2110168, C2110169, C2110170, C2110171, C2110172, C2110173, C2110174, C2110175, C2110176, C2110177, C2110180, C2110181, C2110182, C2110183, C2110184, C2110185, C2110186, C2110187, C2110188, C2110189, C2110190, C2110191, C2110192, C2110193, C2110194, C2110195, C2110196, C2110197, C2110199, C2110200, C2110201, C2110202, C2110203, C2110204, C2110205, C2110206, C2110207, C2110208, C2110209, C2110210, C2110212, C2110213, C2110214, C2110215, C2110216, C2110217, C2110218, C2110219, C2110220, C2110221, C2110222, C2110223, C2110224, C2110225, C2110226, C2110227, C2110228, C2110229, C2110230, C2110231, C2110232, C2110233, C2110234, C2110235, C2110236, C2110237, C2110238, C2110239, C2110240, C2110241, C2110242, C2110243, C2110244, C2110246, C2110247, C2110249, C2110250, C2110251, C2110252, C2110253, C2110254, C2110255, C2110256, C2110257, C2110259, C2110260, C2110261, C2110262, C2110263, C2110264, C2110265, C2110266, C2110267, C2110268, C2110269, C2110270, C2110271, C2110272, C2110273, C2110274, C2110275, C2110276, C2110278, C2110279, C2110280, C2110282, C2110283, C2110284, C2110285, C2110286, C2110287, C2110288, C2110289, C2110291, C2110292, C2110293, C2110295, C2110296, C2110297, C2110298, C2110299, C2110300, C2110301, C2110302, C2110303, C2110304, C2110305, C2110306, C2110307, C2110308, C2110309, C2110310, C2110311, C2110312, C2110313, C2110314, C2110315, C2110317, C2110318, C2110319, C2110320, C2110321, C2110323, C2110325, C2110326, C2110328, C2110331, C2110332, C2110333, C2110334, C2110340, C2110341, C2110342, C2110344, C2110345, C2110346, C2110347, C2110348, C2110349, C2110350, C2110351, C2110352, C2110354, C2110356, C2110357, C2110358, C2110359, C2110360, C2110361, C2110362, C2110371, C2110372, C2110374, C2110375, C2110379, C2110380, C2110381, C2110382, C2110383, C2110384, C2110385, C2110386, C2110387, C2110388, C2110390, C2110391, C2110392, C2110393, C2110394, C2110395, C2110396, C2110398, C2110399, C2110400, C2110401, C2110402, C2110403, C2110404, C2110405, C2110406, C2110407, C2110408, C2110409, C2110410, C2110411, C2110412, C2110413, C2110414, C2110415, C2110416, C2110417, C2110419, C2110420, C2110422, C2110423, C2110424, C2110425, C2110428, C2110429, C2110430, C2110436, C2110437, C2110438, C2110439, C2110440, C2110442, C2110443, C2110445, C2110446, C2110448, C2110449, C2110450, C2110452, C2110453, C2110454, C2110456, C2110457, C2110459, C2110461, C2110462, C2110463, C2110464, C2110466, C2110467, C2110468, C2110472, C2110473, C2110474, C2110475, C2110476, C2110477, C2110478, C2110479, C2110480, C2110481, C2110482, C2110483, C2110484, C2110485, C2110486, C2110487, C2110488, C2110489, C2110490, C2110492, C2110493, C2110494, C2110495, C2110496, C2110497, C2110498, C2110499, C2110500, C2148001, C2148002, C2148003, C2148004, C2148005, C2148006, C2148007, C2148008, C2148009, C2148010, C2148011, C2148012, C2148013, C2148014, C2148015, C2148016, C2148018, C2148019, C2148020, C2148021, C2148022, C2148023, C2148024, C2148025, C2148026, C2148027, C2148028, C2148029, C2148031, C2148032, C2148034, C2148035, C2148036, C2148037, C2148038, C2148039, C2148040, C2148041, C2148043, C2148044, C2148045, C2148046, C2148048, C2148049, C2148050, C2148051, C2148052, C2148053, C2148054, C2148055, C2148056, C2148057, C2148058, C2148059, C2148060, C2148061, C2148062, C2148064, C2148065, C2148066, C2148067, C2148068, C2148069, C2148070, C2148071, C2148072, C2148074, C2148075, C2148076, C2148077, C2148080, C2148082, C2148083, C2148084, C2148085, C2148086, C2148088, C2148089, C2148092, C2148093, C2148094, C2148095, C2148096, C2148097, C2148098, C2148099, C2148101, C2148103, C2148104, C2148105, C2148106, C2148107, C2148108, C2148109, C2148110, C2148111, C2148114, C2148116, C2148117, C2148118, C2148119, C2148120, C2148121, C2148122, C2148125, C2148126, C2148127, C2148128, C2148129, C2148130, C2148131, C2148133, C2148134, C2148135, C2148136, C2148137, C2148138, C2148139, C2148140, C2148141, C2148142, C2148143, C2148144, C2148145, C2148146, C2148147, C2148148, C2148151, C2148153, C2148154, C2148155, C2148156, C2148157, C2148158, C2148159, C2148160, C2148161, C2148162, C2148163, C2148165, C2148169, C2148170, C2148171, C2148172, C2148173, C2148174, C2148175, C2148177, C2148178, C2148180, C2148182, C2148184, C2148185, C2148186, C2148187, C2148188, C2148189, C2148190, C2148191, C2148192, C2148193, C2148194, C2148195, C2148196, C2148197, C2148198, C2148201, C2148203, C2148204, C2148205, C2148206, C2148208, C2148209, C2148210, C2148211, C2148212, C2148213, C2148214, C2148215, C2148216, C2148217, C2148218, C2148219, C2148220, C2148221, C2148222, C2148223, C2148224, C2148225, C2148226, C2148227, C2148228, C2148229, C2148231, C2148232, C2148234, C2148235, C2148236, C2148237, C2148238, C2148239, C2148240, C2148242, C2148243, C2148244, C2148245, C2148246, C2148247, C2148248, C2148249, C2148250, C2148251, C2148252, C2148253, C2148254, C2148255, C2148256, C2148257, C2148258, C2148259, C2148260, C2148261, C2148262, C2148263, C2148264, C2148265, C2148266, C2148267, C2148268, C2148270, C2148271, C2148272, C2148273, C2148274, C2148275, C2148276, C2148277, C2148278, C2148279, C2148280, C2148282, C2148283, C2148284, C2148285, C2148286, C2148287, C2148288, C2148289, C2148290, C2148291, C2148292, C2148293, C2148294, C2148295, C2148296, C2148297, C2148298, C2148299, C2148300, C2148301, C2148303, C2148304, C2148305, C2148306, C2148307, C2148308, C2148309, C2148310, C2148311, C2148312, C2148313, C2148314, C2148315, C2148317, C2148318, C2148319, C2148320, C2148321, C2148322, C2148323, C2148324, C2148325, C2148326, C2148327, C2148328, C2148329, C2148330, C2148331, C2148332, C2148333, C2148334, C2148336, C2148337, C2148338, C2148339, C2148340, C2148341, C2148342, C2148343, C2148344, C2148345, C2148346, C2148347, C2148349, C2148350, C2148351, C2148352, C2148353, C2148354, C2148356, C2148357, C2148358, C2148359, C2148360, C2148361, C2148362, C2148363, C2148368, C2148369, C2148370, C2148371, C2148372, C2148373, C2148374, C2148375, C2148376, C2148377, C2148378, C2148379, C2148380, C2148381, C2148382, C2148383, C2148384, C2148385, C2148386, C2148387, C2148388, C2148389, C2148390, C2148391, C2148392, C2148394, C2148395, C2148396, C2148397, C2148398, C2148399, C2148400, C2148402, C2148403, C2148404, C21484...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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C2148310, C2148311, C2148312, C2148313, C2148314, C2148315, C2148317, C2148318, C2148319, C2148320, C2148321, C2148322, C2148323, C2148324, C2148325, C2148326, C2148327, C2148328, C2148329, C2148330, C2148331, C2148332, C2148333, C2148334, C2148336, C2148337, C2148338, C2148339, C2148340, C2148341, C2148342, C2148343, C2148344, C2148345, C2148346, C2148347, C2148349, C2148350, C2148351, C2148352, C2148353, C2148354, C2148356, C2148357, C2148358, C2148359, C2148360, C2148361, C2148362, C2148363, C2148368, C2148369, C2148370, C2148371, C2148372, C2148373, C2148374, C2148375, C2148376, C2148377, C2148378, C2148379, C2148380, C2148381, C2148382, C2148383, C2148384, C2148385, C2148386, C2148387, C2148388, C2148389, C2148390, C2148391, C2148392, C2148394, C2148395, C2148396, C2148397, C2148398, C2148399, C2148400, C2148402, C2148403, C2148404, C21484...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 31, 2024
Recall initiation date: Jun 24, 2024
Center classification date: Jul 24, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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