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 devise that allows for worklist management, image storage, image processing, image exporting and image

Recall Insight

This FDA Devices action (record #Z-1958-2019) was formally reported on July 17, 2019, with the manufacturer initiating the action on October 16, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Canon Medical System, USA, INC. is listed as the recalling firm, operating out of Tustin, CA. Federal records indicate 46 units are affected.

The documented reason for this recall is: software 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 i… Distribution data in the federal record shows the product reached: US Nationwide Distribution - PA, UT, FL, NY, AR, LA, WV, NJ, OH, MI, WI, TN, TX, VT, GA, NC, IL. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.