Skytron, Div. The KMW Group, Inc: Medical Device Recall in 2022 - (Recall #: Z-1309-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: June 2, 2022
Date Posted: July 6, 2022
Recall Number: Z-1309-2022
Event ID: 90400
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.

Status: Ongoing
Product Quantity: 731
Code Information:

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.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated