Z-1309-2022Class II

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

Name: Z-1309-2022 Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Creator: Skytron, Div. The KMW Group, Inc
Published: 2022-06-02
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2022-06-02 / Open, Classified / root cause: design

FDA source

Skytron, Div. The KMW Group, Inc began a recall of Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A on 2022-06-02. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1309-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-02
Posted: 2022-06-30
Recalling firm: Skytron, LLC
Product: Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Product code: FQO Table, Operating-Room, Ac-Powered
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.
Root cause tag: design
FDA 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 [email protected] with any questions.
Quantity in commerce: 731
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Japan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)