{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "213082", "product_res_number": "Z-1623-2025", "event_date_initiated": "2025-03-10", "event_date_posted": "2025-04-18", "recall_status": "Open, Classified", "res_event_number": "96511", "product_code": "GWF", "k_numbers": [ "K200759" ], "product_description": "NIM Vital Nerve Monitoring System:\nCONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;\t\t\nCONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;\t\t\nPATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;\t\t\nPATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;\t\t\nSOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;\t\t\nSOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;\t\t\nSOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164", "code_info": "All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier.\n\nREF/UDI-DI:\nNIM4CM01/763000002978, 00763000395896, 00763000401597, 00763000528577;\nNIM4CM01RF/00763000002992;\nNIM4CPB1/763000002985, 00763000401603, 00763000395902, 00763000528584;\nNIM4CPB1RF/00763000003005;\nNIM4SWU143/00763000709341, 00763000869823;\nNIM4SWU154/00763000945398;\nNIM4SWU164/00763000974312", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "Marie Gentile\n404-693-6028", "reason_for_recall": "Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.", "root_cause_description": "Software change control", "action": "On 3/10/2025, recall notices were mailed, and/or emailed to customers who were asked to do the following:\n\n1) Your Medtronic representative will contact you to install the new software version 1.7.5 for correction of the impacted product in your possession.\n\n2) For patients who are currently being monitored with affected devices, be aware of the possibility of increased stimulus artifact. Refer to the system instructions for use for instructions on how the stimulus artifact may be reduced or exacerbated through the adjustment of system settings including event threshold, stimulation current, and rejection period.\n\n3) Complete and return the customer confirmation form via email to neuro.quality@medtronic.com\n\n4) Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for your records.\n\nDistributors are asked to discard any of the items below in your inventory:\na. SOFTWARE NIM4SWU143 UPGRADE v1.4.3\nb. SOFTWARE NIM4SWU154 UPGRADE v1.5.4\nc. SOFTWARE NIM4SWU164 UPGRADE v1.6.4\n\nIf you have any questions regarding this communication, please contact the firm's Sales Representative or Technical Services at 1-888-826-5603.", "product_quantity": "9,788", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR 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, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.", "openfda": { "k_number": [ "K843464", "K955257", "K780539", "K051384", "K110140", "K820414", "K112052", "K781704", "K952294", "K896567", "K130346", "K082614", "K200759", "K061113", "K831896", "K820908", "K863175", "K061645", "K123843", "K885246", "K960170", "K233292", "K132616", "K884870", "K010092", "K051864", "K253301", "K051357", "K072343", "K111647", "K971740", "K932994", "K030526", "K926516", "K091457", "K230415", "K844707", "K843253", "K162199", "K000963", "K944547", "K871338", "K142624", "K040358", "K182542", "K903731", "K234080", "K050798", "K002969", 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"K981405" ], "registration_number": [ "3018094310", "3000279201", "1930870", "3003120897", "3008773490", "1047843", "1221763", "3018708317", "2183946", "2184161", "2023374", "3043543260", "2031966", "3010041499", "3010209365", "2027467", "1048735", "3030412764", "3016438694", "3030154814", "3010047454", "2032098", "3005706667", "3006783837", "3003851073", "3012352782", "1319639", "8043933", "3006639944", "3005581270", "3009973336", "9612389", "1052723", "3007770159", "2183456", "1056553", "3013501110", "3003631667", "1526534", "3004753785", "1317188", "9611896", "9615126", "3001687738", "2031093", "1030489", "3023852420", "9611252", "3009973505", "1835251", "3007713076", "8021774", "2133772", "3007147067", "3006418479", "3009959868", "3019878714", "8030229", "1526711", "1119189", "3009050824", "3016852448", "3017448360", "3011766844", "2530126", "3005545216", "1650946", "3007014520", "1824199", "1045254", "3024996452", "2080783", "3009144915", "9613619", "2024311", "9612330", 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