Recall Z-2469-2023— Skytron, LLC
Class II · Ongoing
Class II FDA medical device recall by Skytron, LLC, initiated 2023-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: GS70 Salus Surgical Table, Product Code 18-070-70. Reason: 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..
- Recalling firm
- Skytron, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-01
- Firm location
- Grand Rapids, MI, United States
Product description
GS70 Salus Surgical Table, Product Code 18-070-70
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.