The Recall Desk
HighFDA (Devices)·Z-2469-2023·Announced 2023-09-06

GS70 Salus Surgical Table may continue moving after control button release

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.

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 a Class II medical device recall involving loss of control of a surgical table due to communication interruption between the control pendant and table. The source does not report any injuries or hospitalizations. Per the severity rubric, a risk-of-harm product where injury has not yet been reported is classified as High.

Plain-English summary

Skytron, LLC is recalling 110 units of the GS70 Salus Surgical Table (Product Code 18-070-70). The recall is due to a control defect where the table continues moving after the control button is released.

The issue occurs when communication between the control pendant and surgical table is interrupted while a button is being pressed. When this happens, the table does not know when the button has been released, causing it to continue moving. The defect can occur in both Bluetooth wireless and wired modes. Initially, the root cause was thought to affect only wireless communications, but testing revealed the same failure can occur with wired connections.

The affected units are distributed nationwide across the US states of Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin, as well as Australia and New Zealand.

The recalled product

Product
GS70 Salus Surgical Table, Product Code 18-070-70
Manufacturer
Skytron, LLC
Hazard
  • loss-of-control
  • unintended-movement

Distribution

Distributed nationwide across the United States.