DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System

Recall Insight

This FDA Devices action (record #Z-2463-2012) was formally reported on October 3, 2012, with the manufacturer initiating the action on July 30, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Imaging Sciences International, LLC is listed as the recalling firm, operating out of Hatfield, PA. Federal records indicate 366 units are affected.

The documented reason for this recall is: A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the so… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI a…. 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 14 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.