# FDA recall Z-0109-2021

> **Skytron, Div. The KMW Group, Inc** · Class II · device recall initiated 2020-03-10.

## Product

SkyVision SDS System - Video Integration  Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.

## Reason for recall

Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go  Blank  and the touch panel to display a  Blank image  when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.

## Distribution

US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.

## Key facts

- **Recall number:** Z-0109-2021
- **Recalling firm:** Skytron, Div. The KMW Group, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-10
- **Report date:** 2020-10-21
- **Termination date:** 2021-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2021

## Citation

> AI Analytics. FDA recall Z-0109-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0109-2021. Source: US FDA. Licensed CC0.

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