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.
Reported: September 9, 2020 Initiated: July 24, 2020 #Z-2921-2020
Product Description
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.
Reason for Recall
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 110 units US
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 110 units US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2921-2020.
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