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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 24
Distribution
Part of a larger recall action
This product is one of 2 recalled by Skytron, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Skytron, LLC
See all →- HighGS70 Salus Surgical Table may continue moving after control button release
FDA (Devices) · 2023-09-06
Same hazard · uncontrolled movement
See all →- HighRebstock Holding Rod for Fixation May Move Uncontrollably
FDA (Devices) · 2024-03-06
- HighX-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA (Devices) · 2023-06-07
- HighMedical Device Recall: X-Ray Detector Drive Shaft May Break
FDA (Devices) · 2023-06-07
- Highda Vinci Surgical System Patient Cart Ballscrew Failure Risk
FDA (Devices) · 2023-03-22
- HighMaintainer Service Trucks Recalled for Uncontrolled Crane Movement Risk
NHTSA · 2023-02-07
Similar recalls
- HighSteris Surgical Table Recalled for Potential Unintended Movement
FDA (Devices) · 2012-09-26
- HighSkytron EZ Slide Operating Table Recalled for Potential Slide Cap Detachment
FDA (Devices) · 2016-06-08
- HighOperating Table May Stop Unexpectedly During Surgery Due to Control Error
FDA (Devices) · 2024-11-20
- SevereMedtronic Mazor X Surgical System Positioner Recalled for Detachment Risk
FDA (Devices) · 2020-06-17
- HighTrumpf TITAN Operating Room Table Recalled for Unintended Movement
FDA (Devices) · 2014-11-05
- SevereSenhance Robotic Surgical System uncontrolled arm motion malfunction
FDA (Devices) · 2023-11-08