Generic Name: Whole-body X-ray Ct Diagnostic System — Trade Name: Whole-body X-ray Ct Diagnostic System Scenaria View

Recalling firm: Name of Manufacturer and Distributor: Fujifilm Corporation — Address of Manufacturer and Distributor: 798 Miyadai, Kaisei-machi, Ashigarakami-gun, Kanagawa Prefecture — Type of License: Class I...
Product: Lot: 全身用X線CT診断装置 SCENARIA View G130002118 G130002519 G130005818 G130008619 G130009218 G130015819 G130016518 G130033019 G130049524 G1Z0000223 G1Z0010923 G1Z0029722 G1Z0049923 G1Z0055822 G1Z0056022 G1Z0077621 G1Z0110621 G1Z0111523 G1Z0112221 G1Z0112321 G1Z0127621 G1Z0129621 G1Z0130021 G1Z0131921 G1Z0133321 G1Z0144122 G1Z0149221 G1Z0161222 G1Z0175022 G1Z0182222 G1Z0193822 G1Z0195122 G1Z0222921 G1Z0256621 G1Z0314022 G1Z0321822 G1Z0340421 G1Z0340521 G1Z0340821 G560000420 G560002220 G560002820 G560003720 G560028519 G560037219 G560055419 G560064819 G560077219 G560077819 数量：49台...
Reason: We have discovered that if the timing of pressing the “Warm-up and Prepare for Imaging” button on the control room console coincides with the operation of the patient table inside the gantry, there is a rare risk of unintended X-ray exposure occurring before the “Start Imaging” button on the control room intercom box is pressed. Therefore, we will perform a voluntary recall to install software that addresses this issue.
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/b9bee684-646d-4e95-b1dc-a6e7d330ac2c