# FDA recall Z-2921-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-07-24.

## 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.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2921-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-24
- **Report date:** 2020-09-09
- **Termination date:** 2021-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2921-2020

## Citation

> AI Analytics. FDA recall Z-2921-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2921-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*