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.
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. Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of Australia, New Zealand. Quantity: 24 units Lot/code info: Serial Numbers:SUC-20207-0002 SUC-20208-0006 SUC-20209-0010 SUC-2020X-0014 SUC-2022Z-0018 SUC-20233-0022 SUC-20207-0003 SUC-20208-0007 SUC-20209-0011 SUC-2020X-0015 SUC-2022Z-0019 SUC-20233-0023 SUC-20208-0004 SUC-20209-0008 SUC-2020X-0012 SUC-2020X-0016 SUC-2022Z-0020 SUC-20233-0024 SUC-20208-0005 SUC-20209-0009 SUC-2020X-0013 SUC-2022Z-0017 SUC-2022Z-0021 SUC-20233-0025
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.