—#180463

Product

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

FDA product code: DXQ — Blood Pressure Cuff
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K152006
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None

Timeline

Recall initiated: 2019-07-12
Terminated: 2023-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.