medical Class II Updated 2020-05-13

ICU Medical, Inc. recalls The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN

Recalled 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.


Hazard / Issue

Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

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