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.
What this means for you
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.
- 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
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