Z-1835-2020Class II

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

Name: Z-1835-2020 ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Creator: ICU Medical, Inc.
Published: 2019-07-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-07-12 / Terminated / root cause: software

FDA source

ICU Medical, Inc. began a recall of ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 on 2019-07-12. FDA classified it as Class II and gives the reason as "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...". 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-1835-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-12
Posted: 2020-05-01
Terminated: 2023-05-10
Recalling firm: Abbott Medical
Product: ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Product code: DXQ Blood Pressure Cuff
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1835-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30

Product code DXQ

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)