The Recall Desk
HighFDA (Devices)·Z-2470-2023·Announced 2023-09-06

Skytron GS70H Surgical Table Recall: Control Failure Causes Continued Movement

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a functional control failure on a surgical table that poses a risk of unexpected movement during surgery, meeting the rubric criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The Skytron GS70H Salus Surgical Table (Product Code 18-071-70) is subject to recall. The operating table's control pendant has a functional defect where the table continues moving even after the operator releases the control button.

The defect occurs when communication between the control pendant and the surgical table is interrupted while a button is being pressed. Under these circumstances, the table does not know whether or when the button has been released, and continues moving. This malfunction can occur in both wireless (Bluetooth) and wired operating modes.

Twenty-four units have been distributed worldwide. Within the United States, affected units are located in Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. Additional units were distributed to Australia and New Zealand.

The recalled product

Product
GS70H Salus Surgical Table, Product Code 18-071-70
Manufacturer
Skytron, LLC
Hazard
  • uncontrolled-movement
  • communication-failure

Distribution

Distributed nationwide across the United States.