Product Name: GCX Channel Mounting Accessory recallZ-1309-2022 · Skytron, Div. The KMW Group, Inc · initiated Jun 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Skytron, Div. The KMW Group, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component design/selection
What the company is doing
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 [email protected] with any questions.
Recall details
- Recall number
- Z-1309-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2022
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Quantity
- 731
- Product code
- FQO
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Japan.
Product description
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ergon Boom Series Ergon 3Skytron LLC · Light, surgical, ceiling mounted1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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