Medtronic Xomed, Inc.: NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM

Hazard

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.

Details from the source

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. Distribution: 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, C Quantity: 9,788 Lot/code info: All NIM Vital Nerve Monitoring Systems manufactured or installed with software version v1.6.4 or earlier. REF/UDI-DI: NIM4CM01/763000002978, 00763000395896, 00763000401597, 00763000528577; NIM4CM01RF/00763000002992; NIM4CPB1/763000002985, 00763000401603, 00763000395902, 00763000528584; NIM4CPB1RF/00763000003005; NIM4SWU143/00763000709341, 00763000869823; NIM4SWU154/00763000945398; NIM4SWU164/00763000974312

UPC codes

763000002978, 00763000395896, 00763000401597, 00763000528577, 00763000002992, 763000002985, 00763000401603, 00763000395902, 00763000528584, 00763000003005, 00763000709341, 00763000869823, 00763000945398, 00763000974312

Source

Official record: FDA (Device enforcement) ↗

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