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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1224-2022 |
Event ID | 90163 |
Event Description | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France. |
Quantity | 29 units |
Recall Reason | Software anomaly was identified. |
Device Classification | 20220608 |
Device Code Info | Model 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 Date | 20220602 |
Recall Initiation Date | 20220503 |
Recalling Firm | Medtronic Xomed, Inc. |
Initial Notification | Letter |
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