Reported May 6, 2020 · Terminated
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000
- UDI(01)00840619079499
- Lot codes and dates
- 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.
- Amount recalled
- 83 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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