Recall Z-1309-2022 ยท FQO Table, Operating-Room, Ac-Powered
Skytron, Div. The KMW Group, Inc
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
| Date | Jun 2, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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 que |
| Quantity | 731 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.