Medical device recalls Moderate risk

Skytron, Div. The KMW Group, Inc recalls Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

Recall date
June 2, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1309-2022
FDA classification
Class II
Brand / firm
Skytron, Div. The KMW Group, Inc
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada and Japan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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