FDA Device recall Z-1309-2022
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A by Skytron Div The Kmw Group, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1309-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-02 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Skytron Div The Kmw Group |
| Distribution | US |
Product
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
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.
Identifiers
| 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…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1309-2022%22
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