Recall Z-0496-2018 ยท DQK Computer, Diagnostic, Programmable
Edwards Lifesciences, LLC
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hem
| Date | Jan 16, 2018 (initiated Oct 2, 2017) |
| Status | Terminated |
| Reason | Pre-procedural issues related to software defects |
| Root cause | Device Design |
| Action | Consignees were sent recall notification letters on approximately 10/11/2017. The letter identified the affected product, problem and actions to be taken. instructions included coordination with the respective Edwards representative to schedule the software upgrade. |
| Quantity | 198 devices |
| Distribution | US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC, Apr 14, 2017 |