Biplane cardiovascular X-ray system (Floor Mounted) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Risk of interruption in treatment/procedure due to an inability to move the table as the motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm.The reboot will take approximately 90 seconds during which time the table top is free floating. Motorised movements (height, tilt, and cradle) are not possible. Basic imaging will be available.We have received a report of this issue leading to delay during emergency treatment (introduction of a chest drain during cardiac arrest).The problem may arise if a user is performing a manual swing movement of the C-arm at the same time as another user requests a “short” motorised movement via the tableside module.The movement affected is the Beam Swing only (movement D in image below).During the restart the table top is free floating, allowing it to be moved manually in a transverse as well as a longitudinal direction. Motorised movements (height, tilt, and cradle) are not possible during this restart period.