FDA-Device2023-09-06Class II

GS70H Salus Surgical Table, Product Code 18-071-70

Skytron, LLC
Hazard

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.

Sold states
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.
Affected count
24 units
Manufactured in
5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, United States
Products
GS70H Salus Surgical Table, Product Code 18-071-70

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2470-2023

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