# FDA recall Z-0226-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-10-05.

## Product

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo  Model 11007641 (3)Sensis Vibe Combo  Model 11007642  Intended Use:  A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

## Reason for recall

System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0226-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-05
- **Report date:** 2021-11-24

- **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-0226-2022

## Citation

> AI Analytics. FDA recall Z-0226-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0226-2022. Source: US FDA. Licensed CC0.

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