DEXIS Imaging Suite — Class II medical device recall Z-2463-2012
Terminated recall by Imaging Sciences International, LLC, reported 2012-10-03, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering i
| Recall number | Z-2463-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imaging Sciences International, LLC, Hatfield, PA, United States |
| Recall initiated | 2012-07-30 |
| Classified | 2012-09-26 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2016-10-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | CA |
| Quantity | 366 |
| Reason classes | software |
| Model numbers | 1.008.7932 |
Product
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Reason for recall
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 software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2463-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.