Recall Z-1775-2018 ยท DXQ Blood Pressure Cuff
ICU Medical, Inc.
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
| Date | Jan 5, 2018 |
| Status | Terminated |
| Reason | When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode. |
| Root cause | Software design |
| Action | On about 01/05/2018 customers were notified via an Urgent: Medical Device Correction letter of the recall. The letter identified the affected device and the reason for the correction. Instructions included to inspect current inventory for affected devices and complete and return the Urgent: Medical device Correction Response Form to recall@icumed.com. Customers were notified that they did not need to discontinue using the Cogent Hemodynamic Monitoring System (HMS), but were instructed to disconnect the thermal coil cable from the monitor to discontinue continuous cardiac output (CCO) instea |
| Quantity | 36 devices |
| Distribution | Distributed to the states of CA, FL, NC, NE, NY, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152006 | Cogent Hemodynamic Monitoring System Icu Medical, Inc., May 5, 2016 |