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U.S. Department of Health and Human Services

Class 2 Device Recall GCX Channel Mounting Accessory

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 Class 2 Device Recall GCX Channel Mounting Accessorysee related information
Date Initiated by FirmJune 02, 2022
Create DateJune 30, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1309-2022
Recall Event ID 90400
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductProduct Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
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.
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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 quality@skytron.com with any questions.
Quantity in Commerce731
DistributionWorldwide distribution - US Nationwide and the countries of Canada and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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