Recall Z-1835-2020
ICU Medical, Inc. · initiated July 12, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1835-2020
- Initiated
- July 12, 2019
- Terminated
- May 10, 2023
- Product code
- DXQ – Blood Pressure Cuff
- Quantity
- 83 units
- Distribution
- US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
- Recalling firm
- ICU Medical, Inc., San Clemente, CA