Recall Z-1835-2020 ยท DXQ Blood Pressure Cuff
ICU Medical, Inc.
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
| Date | Jul 12, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152006 | Cogent Hemodynamic Monitoring System Icu Medical, Inc., May 5, 2016 |