Class II — Skytron, LLC
| Recalling firm | Skytron, LLC |
|---|---|
| Registered facility | Skytron, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode. |
| Product | GS70 Salus Surgical Table, Product Code 18-070-70 |
| Quantity | 110 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of Australia, New Zealand. |
| Initiated | 2023-08-01 |
| Classified | 2023-08-28 |
| Recall number | Z-2469-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Skytron, LLC (Z-2469-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92290/
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