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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 February 14, 2020
Create Date May 07, 2020
Recall Status1 Terminated 3 on May 03, 2023
Recall Number Z-1927-2020
Recall Event ID 85329
510(K)Number K152006  
Product Classification Computer, diagnostic, pre-programmed, single-function - Product Code DXG
Product The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.
Code Information All serial numbers of Cogent HMS, List Number(s): 58400-000; 58400-000R; 58403-000; 58401-000 with Software Versions 1.3.3.42 and prior are impacted.
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact ICU Medical
844-654-7780
Manufacturer Reason
for Recall		 Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
FDA Determined
Cause 2		 Software Design Change
Action On 14 February 2020, the firm sent notification of the recall to direct consignees of record. Delivery will be confirmed via traceable mailing. All consignees who further distributed the product were asked to notify their customers
Quantity in Commerce 123 units
Distribution US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.
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 = DXG and Original Applicant = ICU MEDICAL INC.
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