# FDA recall Z-2441-2024

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2024-07-03.

## Product

Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations.    Model: 11007641

## Reason for recall

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

## Distribution

US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.

## Key facts

- **Recall number:** Z-2441-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-03
- **Report date:** 2024-07-31

- **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-2441-2024

## Citation

> AI Analytics. FDA recall Z-2441-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2441-2024. Source: US FDA. Licensed CC0.

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