Siemens Sensis Vibe Hemo System Recalled for Connector Defect
Siemens is recalling 110 Sensis Vibe Hemo systems because a connector may break, potentially causing the device to stop functioning and lose vital signs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the loss of vital signs in a medical device, which poses a risk of harm even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 110 units of the Siemens Sensis Vibe Hemo system in combination with the MicroPod EtCO2 module. These devices are diagnostic and administrative tools used to support hemodynamic catheterization and electrophysiology studies in cardiac and interventional radiology settings. The affected units were distributed nationwide in the United States.
The recall is due to a defect where the connector linking the EtCO2 module to the HemoBox may break and become damaged. If the connector is re-attached to the HemoBox while in this damaged state, specific incorrect pin alignment conditions may cause the HemoBox to stop functioning. This failure results in the loss of all vital signs.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 110
Distribution
Distributed nationwide across the United States.
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