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Medtronic Xomed, Inc. Recall 90163

Description: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Medtronic Xomed, Inc. Recall 90163 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1223-2022
Event ID90163
Event DescriptionNIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Quantity18 units
Recall ReasonSoftware anomaly was identified.
Device Classification20220608
Device Code InfoModel Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.
Center Classification Date20220602
Recall Initiation Date20220503
Recalling FirmMedtronic Xomed, Inc.
Initial Notification Letter
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