PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 6, 2023 Initiated: August 1, 2023 #Z-2470-2023

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Skytron, LLC
Units Affected
24 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.
Location
Grand Rapids, MI

Frequently Asked Questions

What product was recalled?
GS70H Salus Surgical Table, Product Code 18-071-70. Recalled by Skytron, LLC. Units affected: 24 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2470-2023.