FDA (Devices) recall action 92290
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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, t…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.
The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.