ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue
ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.
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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect diagnostic data) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 220 units of the Cogent Hemodynamic Monitoring System. The recall is due to a potential software issue that may cause the device display to show incorrect continuous cardiac output (CCO) values after PulseCO calibration.
The affected devices were distributed nationwide in the United States, including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA, and WI. The recall includes specific serial numbers and item codes listed in the official FDA notice.
Healthcare facilities should identify affected units by checking the serial numbers against the provided list. Users should contact ICU Medical for instructions on how to resolve the software issue.
The recalled product
- Product
- icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 220
Distribution
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