ClearanceBrief
Recall Z-1958-2019 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Canon Medical System, USA, INC.

Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devis

DateOct 16, 2018
StatusTerminated
Reasonsoftware malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.
Root causeSoftware design
ActionOn October 16, 2019, the firm sent an urgent medical device correction letter via USPS, return receipt to all customers who were distributed the affected device. The notification letter ask customers to do the following: 1. Should the problem occur before the modified software is installed on your system, please reduce the number of other devices which use the same wireless channel as this system as much as possible to avoid heavy wireless traffic. 2. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your faci
Quantity46
DistributionUS Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K122842RADREX-I, SW V4.00 MODEL DRAD-3000E
Toshiba America Medical Systems, In.C, Oct 9, 2012