Medtronic Xomed, Inc.: 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

Hazard

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

Details from the source

Reason for recall: Potential for false negative response on the NIM Vital Nerve Monitoring System 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, Ho Quantity: 7,804 units Lot/code info: 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,

UPC codes

00763000002978, 00763000395896, 00763000401597, 00763000528577, 00763000002992, 00763000002985

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.