Cl ll DEXIS Imaging Suite

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

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.