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Open, Classified

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

FDA Recall Z-1309-2022 · Posted None

Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusOpen, Classified
Product CodeFQO
Date Initiated2022-06-02
Product Quantity731

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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