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
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