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U.S. Department of Health and Human Services

Class 2 Device Recall Cogent" Hemodynamic Monitoring System

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  Class 2 Device Recall Cogent" Hemodynamic Monitoring System see related information
Date Initiated by Firm July 12, 2019
Create Date May 01, 2020
Recall Status1 Terminated 3 on May 10, 2023
Recall Number Z-1835-2020
Recall Event ID 85300
510(K)Number K152006  
Product Classification blood pressure cuff - Product Code DXQ
Product ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Code Information All serial numbers of Cogent HMS, PN 58400-000, PN 58400-000R (User Interface Module (UIM), PN 58403-000 and Patient Interface Module (PIM), PN 58401-000) with Software Versions 1.3.2.460 and prior are impacted. 
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact ICU Medical
1866-829-9025 Ext. 4
Manufacturer Reason
for Recall		 Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified of the recall via UPS letter on 7/12/2019. The firm is voluntarily notifying customers and will contact customers to schedule a software update once the updated software is available. The firm has instructed customers to use the mitigation instructions detailed in the customer letter to reduce the likelihood of the software conditions occurring. The firm also requested customers complete a response form and return it to the firm. For additional information or technical assistance contact ICU Medical at 1-866-829-9025, option 4.
Quantity in Commerce 83 units
Distribution US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXQ and Original Applicant = ICU MEDICAL INC.
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