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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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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.
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