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Medtronic Xomed, Inc. Recall 90163

Description: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Medtronic Xomed, Inc. Recall 90163 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1224-2022
Event ID90163
Event DescriptionNIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) 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.
Quantity29 units
Recall ReasonSoftware anomaly was identified.
Device Classification20220608
Device Code InfoModel Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Center Classification Date20220602
Recall Initiation Date20220503
Recalling FirmMedtronic Xomed, Inc.
Initial Notification Letter
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