Following Shimadzu's investigation, it was noted that there is a potential issue with the system software that could cause: 1) The x-ray irradiation rate (pulse rate) of pulse fluoroscopy to be different then set value, 2) The beam hardening filter during fluoroscopy to be different then set value, 3) The calculated dose displayed on the screen to be higher than actual dose (the correct does is displayed if an area dosimeter is installed). The malfunctions could lead to improper measurements of pulse rate, setting of beam hardening filter and/or inaccurate dose displayed on display screen. Recall start date: Mar 23, 2022
RecallTracker