medical Class II Updated 2020-05-06

ICU Medical, Inc. recalls ICU Medical Cogent Hemodynamic Monitoring System, Cogent Ite

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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.
View official government recall

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