FDA Medical Device Recalls (openFDA)
Skytron, Div. The KMW Group, Inc: Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
- Recall number
- Z-1309-2022
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Product
- Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
- Status
- Open, Classified
- Initiated
- 2022-06-02
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Component design/selection
- Action
- On June 2, 2022, the firm sent out Urgent Medical Device Correction letters to affected customers. Customers were instructed to identify their GCX Channel Mounting Accessories used with Ergon 3 booms. Customers should inspect their mounting accessories. If the user sees that the channel is tilted on the VST clamp, this could indicate that the screws or tension knob have loosened. Remove the device from service if you find evidence that it may fail. Skytron authorized representatives will contact customers to schedule a service visit. Please contact quality at quality@skytron.com with any questions.
- Quantity
- 731
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Japan.
- Lot, serial or model codes
- Lot Code: All units of model H8-300-40-A are affected. Code Info: GCX mounting bracket does not have UDI. Ergon 3 booms after September 2016 have UDI. DI of units manufactured after September 2016 is 10841736100889. Units manufactured prior to September 2016 do not have UDI.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 1825014
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28