# FDA recall Z-1434-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-03-04.

## Product

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows:    Dedicated SIS Server- 6648153  Sensis Post-Processing Workstation- 6648161  Sensis- 10764561  VM Virtual Server- 10765502  Sensis High-End Servers- 10910620  Sensis Vibe Hemo- 11007641  Sensis Vibe Combo- 11007642    Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

## Reason for recall

Due to the configuration of certain  Windows Service Permissions  within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or  Denial of Service  attacks and could result in incorrect diagnostic or therapeutic decisions

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1434-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-04
- **Report date:** 2021-04-28
- **Termination date:** 2024-09-30

- **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-1434-2021

## Citation

> AI Analytics. FDA recall Z-1434-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1434-2021. Source: US FDA. Licensed CC0.

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