Skytron, LLC recalls GS70 Salus Surgical Table, Product Code 18-070-70

Recall date

August 1, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2469-2023

FDA classification

Class II

Brand / firm

Skytron, LLC

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GS70 Salus Surgical Table, Product Code 18-070-70