ICU Medical Cogent Hemodynamic Monitoring System recall: Software Issue
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Why was ICU Medical Cogent Hemodynamic Monitoring System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 83 units
- Distribution
- US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)