FDA-Device2020-09-09Class II
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.
Hazard
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
Sold states
US Nationwide distribution.
Affected count
110 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2921-2020More Siemens Medical Solutions USA, Inc recalls
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