High FDA (Devices)·Z-0109-2021·Announced 2020-10-21

SkyVision SDS System Recalled for Intermittent Video Signal Failure

Skytron is recalling 36 SkyVision SDS System units because intermittent signal failures can cause monitors to go blank during surgery, increasing patient risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a loss of visual information during surgery, which the source states increases risk to the patient, but no specific injuries or deaths are reported in the text.

Plain-English summary

Skytron, Div. The KMW Group, Inc. is recalling 36 units of the SkyVision SDS System - Video Integration (Model: GC-SDS-BSCB-200). This device is a self-contained video switching and control unit used in operating rooms. The recall is due to an intermittent failure of the signal sent from the touch panel display to the monitor.

When this failure occurs, the displaying monitor and the touch panel may show a blank image. The source text notes that if this issue happens during a surgical case, it increases the risk to the patient because the hospital loses the visual image. The affected units were distributed nationwide in the United States, including in California, Florida, Iowa, Michigan, Minnesota, New York, Pennsylvania, Texas, and Washington.

Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Skytron for repair or replacement.

The recalled product

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.
Manufacturer: Skytron, Div. The KMW Group, Inc
Category: Medical Device — Operating Room Equipment
Hazard: signal-failure
loss-of-visual
Affected units: 36

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Skytron, Div. The KMW Group, Inc

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Same hazard · signal failure