—#180537

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.

FDA product code: DXG — Computer, Diagnostic, Pre-Programmed, Single-Function
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K152006
Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Software Design Change

Action the firm took

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

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.

Timeline

Recall initiated: 2020-02-14
Terminated: 2023-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.