Agency classClass IIOur severity:High FDA (Devices)·Z-1835-2020·Announced 2020-05-06

ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues

ICU Medical is recalling 83 Cogent Hemodynamic Monitoring Systems due to software issues that may cause inaccurate data, unit shutdown, or loss of display.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (inaccurate monitoring data or shutdown) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

ICU Medical, Inc. is recalling 83 units of the Cogent Hemodynamic Monitoring System (Item Number 58400-000) due to software issues identified during internal testing. The affected units are distributed nationwide in Florida, Wisconsin, New York, North Carolina, Vermont, Illinois, Maryland, California, Nebraska, and Washington.

The software issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter. The recall includes all serial numbers of the Cogent HMS with Part Numbers 58400-000, 58400-000R (User Interface Module), 58403-000, and 58401-000 (Patient Interface Module) running Software Versions 1.3.2.460 and prior.

Healthcare facilities should contact ICU Medical for instructions on how to resolve the software issues. The source text does not specify a specific action for consumers, as this is a medical device used in clinical settings.

The recalled product

Product: ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Hemodynamic Monitoring
Hazard: software-defect
inaccurate-data
Affected units: 83

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · ICU Medical, Inc.

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