Recall Z-1002-2013 ยท LLZ System, Image Processing, Radiological
Vital Images, Inc.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images fr
| Date | Mar 27, 2013 (initiated Feb 5, 2013) |
| Status | Terminated |
| Reason | Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia |
| Root cause | Software design |
| Action | Vital Images sent an "Urgent Field Safety Notice' letter dated February 5, 2013, to all affected customers. The letter identified the probelm the product and the action needed to be taken by the customer. Please immediately inform all potential users of Vitrea of the information contained in this letter. We recommend that all measurements associated with the error described in this letter be verified against results from other technologies. You will be contacted by Vital Images Customer Support or by the customer support department of your distributor to arrange for installation of this |
| Quantity | 7649 (Expnaded 5/28/13 to 7654) |
| Distribution | Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO |
| FDA record | Open on fda.gov |