Enforcement Report - Week of October 3, 2012
-
Back to Previous Page
Product Detail
| Product Description | DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System |
|---|---|
| Recall Number | Z-2463-2012 |
| Classification | Class II |
| Code Info | Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 |
| Product Distributed Qty | 366 |
| 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) DEXIS Imaging Suite versions 10.0.0 - 10.0.3 must be installed, 2) The DEXCopy feature Mus thave been used to renumber the patient database, and 3) Two or more patients with identical names must be present within the database. |
Event Detail
| Event Id | 62830 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Imaging Sciences International, LLC |
| City | Hatfield |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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 and the country of Canada. |
-
