Grand Rapids, MI, United States
Skytron, Div. The KMW Group, Inc recalls
6 recalls recorded since 2018, most recently on 2 June 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)3
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 June 2022
- Reason
- Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1309-2022
- Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Ongoing Class II Medical devices
- Recall started
- 11 May 2021
- Reason
- Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1861-2021
- Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
Terminated Class II Medical devices
- Recall started
- 11 September 2020
- Terminated
- 24 September 2024
- 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
- Distribution
- AZ, MI, MS, NJ, PA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0071-2021
- 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 op
Terminated Class II Medical devices
- Recall started
- 10 March 2020
- Terminated
- 1 June 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0109-2021
- 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.
Ongoing Class II Medical devices
- Recall started
- 5 March 2020
- Reason
- Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
- Distribution
- AZ, CO, GA, IL, MI, MN, NJ, PA, VA, VT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1569-2020
- Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Terminated Class II Medical devices
- Recall started
- 18 April 2019
- Terminated
- 17 April 2020
- Reason
- Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
- Distribution
- US Nationwide Distribution - AK, IA, MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1779-2019
- Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressur
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.