Recall Z-1927-2020 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
ICU Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - 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. The target population in
| Date | Feb 14, 2020 |
| Status | Terminated |
| Reason | Firm identified software issues which leads to the patient ID and patient information not being stored in the system. |
| Root cause | Software Design Change |
| Action | On 14 February 2020, the firm sent notification of the recall to direct consignees of record. Delivery will be confirmed via traceable mailing. All consignees who further distributed the product were asked to notify their customers |
| Quantity | 123 units |
| Distribution | US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152006 | Cogent Hemodynamic Monitoring System Icu Medical, Inc., May 5, 2016 |