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Terminated

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

FDA Recall Z-1835-2020 · Posted None

Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDXQ
Date Initiated2019-07-12
Date Terminated2023-05-10
Product Quantity83 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152006Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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