FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
- Recall number
- Z-1835-2020
- Recalling firm
- ICU Medical, Inc.
- Product
- ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
- Status
- Terminated
- Initiated
- 2019-07-12
- Posted
- not on file
- Terminated
- 2023-05-10
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Customers were notified of the recall via UPS letter on 7/12/2019. The firm is voluntarily notifying customers and will contact customers to schedule a software update once the updated software is available. The firm has instructed customers to use the mitigation instructions detailed in the customer letter to reduce the likelihood of the software conditions occurring. The firm also requested customers complete a response form and return it to the firm. For additional information or technical assistance contact ICU Medical at 1-866-829-9025, option 4.
- Quantity
- 83 units
- Distribution
- US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K152006"]
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28