# FDA recall Z-1173-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-01-27.

## Product

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC.  Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies  Model Numbers:  Sensis Vibe Hemo 11007641  Sensis Vibe Combo 11007642  Sensis 10764561  Postprocessing Workstation 6648161  SIS Server 6648153

## Reason for recall

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

## Distribution

US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.

## Key facts

- **Recall number:** Z-1173-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-27
- **Report date:** 2021-03-10
- **Termination date:** 2021-10-25

- **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-1173-2021

## Citation

> AI Analytics. FDA recall Z-1173-2021. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-1173-2021. Source: US FDA. Licensed CC0.

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