Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
- Company
- Skytron, Div. The Kmw Group, Inc
- Recall Initiated
- June 2, 2022
- Recall Number
- Z-1309-2022
- Quantity
- 731
- Firm Location
- Grand Rapids, MI
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.
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.
Root Cause
Component design/selection
Action Taken
On 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.