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

FDA Recall #Z-1309-2022 — Class II — June 2, 2022

Recall #Z-1309-2022 Date: June 2, 2022 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Skytron, Div. The KMW Group, Inc — Grand Rapids, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

731

Distribution

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

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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