DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Recall Insight

This FDA Devices action (record #Z-0798-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on November 25, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Carestream Health, Inc. is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate 493 units Total (107 units domestically & 386 units internationally) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finla…. 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 12 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.