NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- May 3, 2022
- Posted
- June 2, 2022
- Recall Number
- Z-1223-2022
- Quantity
- 18 units
- Firm Location
- Jacksonville, FL
Reason for Recall
Software anomaly was identified.
Distribution
Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Lot / 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.
Root Cause
Software Design Change
Action Taken
The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.