Recall Z-0071-2021— Skytron, Div. The KMW Group, Inc
Class II · Terminated
Class II FDA medical device recall by Skytron, Div. The KMW Group, Inc, initiated 2020-09-11, terminated 2024-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.. Reason: VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display.
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-11
- Terminated
- 2024-09-24
- Firm location
- Grand Rapids, MI, United States
Product description
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
Reason for recall
VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
Data sourced from openFDA. This site is unofficial and independent of the FDA.