Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Summary
The FDA issued a Class II for Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A by Skytron, Div. The KMW Group, Inc. 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 Ac.
Details
Source
Device Recall
External ID
Z-1309-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Lot/Code Info: 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.
Quantity Affected: 731
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-02
Company
Grand Rapids, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Skytron, Div. The KMW Group, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Skytron, Div. The KMW Group, Inc have FDA actions?
This is the only FDA action we have on record for Skytron, Div. The KMW Group, Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1309-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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