Recall Z-2921-2020 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
| Date | Aug 28, 2020 (initiated Jul 24, 2020) |
| Status | Terminated |
| Reason | The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost |
| Root cause | Process design |
| Action | Siemens issued Customer Safety Advisory Notice distributed dated July 24 2020 to customers via AX048/20/S. Letter states reason for recall, health risk and action to take: If the connector linking the EtCO2 module to the HemoBox should become damaged or break, the operator shall not attempt to fix the connector or re-connect the cable to the HemoBox. Only Siemens Customer Service representative or a service provider authorized by Siemens Healthineers may resolve the issue. Siemens strongly recommends that you do not attempt to fix the connector or re-connect the cable to the HemoBox until the |
| Quantity | 110 units US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |