Skytron, LLC
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Skytron, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-09-06FDA-DeviceClass IIGS70H Salus Surgical Table, Product Code 18-071-70
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.
- 2023-09-06FDA-DeviceClass IIGS70 Salus Surgical Table, Product Code 18-070-70
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.
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