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U.S. Department of Health and Human Services

Class 2 Device Recall NIM Vital 4.0 Patient Interface

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 Class 2 Device Recall NIM Vital 4.0 Patient Interfacesee related information
Date Initiated by FirmMay 03, 2022
Date PostedJune 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1224-2022
Recall Event ID 90163
510(K)NumberK200759 
Product Classification Stimulator, electrical, evoked response - Product Code GWF
ProductNIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Code Information 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
FEI Number 1045254
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactMarie Gentile
904-296-9600
Manufacturer Reason
for Recall		Software anomaly was identified.
FDA Determined
Cause 2		Software Design Change
ActionThe 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.
Quantity in Commerce29 units
DistributionWorldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWF
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