Recall Register

Food, drugs, devices › Skytron, Div. The KMW Group, Inc

Device recall: Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

FDA enforcement event 90400 · Class II · initiated 2 Jun 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordGrand Rapids, MI

Skytron, Div. The KMW Group, Inc (Grand Rapids, MI) initiated this device recall on 2 Jun 2022; FDA lists 1 product record under event 90400, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Skytron, Div. The KMW Group, Inc has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Skytron, Div. The KMW Group, Inc, Grand Rapids, MI.

Reason for recall

"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."

Product records

Recall numberProductQuantityClassStatusReport date
Z-1309-2022Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A731Class IIOngoing6 Jul 2022

Context

88%of 2022 device events are Class II839 events that year
1product record in this eventfirm median: 1
9events on this register for the firm

Other enforcement events for Skytron, Div. The KMW Group, Inc

InitiatedProduct (first record)TypeClassRecords
11 May 2021Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch DeviceClass II1
11 Sep 2020VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration CDeviceClass II1
10 Mar 2020SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained videoDeviceClass II1
5 Mar 2020Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part numbeDeviceClass II1
18 Apr 2019Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam DeviceClass II1
6 Apr 2016EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical TablDeviceClass II1
28 Mar 2016Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen sizeDeviceClass II1
2 Dec 2015Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applicatDeviceClass II1

All 9 events for Skytron, Div. The KMW Group, Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada and Japan."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.