Company:Imaging Sciences International, LLC
Date of Enforcement Report 9/26/12
Class ll:
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
Imaging Sciences International, LLC., Hatfield, PA on 7/30/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
366
DISTRIBUTION
Nationwide and Canada
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