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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1223-2022 |
| Event ID | 90163 |
| Event Description | NIM Vital Console 4.0 (P/N: NIM4CM01) 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 | 18 units |
| Recall Reason | Software anomaly was identified. |
| Device Classification | 20220608 |
| Device Code Info | Model 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 Date | 20220602 |
| Recall Initiation Date | 20220503 |
| Recalling Firm | Medtronic Xomed, Inc. |
| Initial Notification | Letter |
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