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Recall Observatory FDA recall evidence

Device product

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

Z-1309-2022

June 02, 2022

Class II

Product summary

Firm
Skytron, Div. The KMW Group, Inc
Event
Event 90400
Status
Ongoing
Classification
Class II
Quantity
731
Official record key
device-enforcement:Z-1309-2022

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.