Z-1927-2020Class II

The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN...

Name: Z-1927-2020 The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN...
Creator: ICU Medical, Inc.
Published: 2020-02-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-02-14 / Terminated / root cause: software

FDA source

ICU Medical, Inc. began a recall of The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401... on 2020-02-14. FDA classified it as Class II and gives the reason as "Firm identified software issues which leads to the patient ID and patient information not being stored in the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1927-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-14
Posted: 2020-05-07
Terminated: 2023-05-03
Recalling firm: Abbott Medical
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.
Product code: DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Reason for recall: Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07

Product code DXG

K152006Class IICogent Hemodynamic Monitoring SystemIcu Medical, Inc. / cleared 2016-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)