Recall Z-1181-2013 ยท LLZ System, Image Processing, Radiological
Vital Images, Inc.
Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
| Date | Apr 26, 2013 (initiated Mar 15, 2013) |
| Status | Terminated |
| Reason | Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment. |
| Root cause | Labeling design |
| Action | Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, support@vitalimages.com. |
| Quantity | 1,978 |
| Distribution | Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GE |
| FDA record | Open on fda.gov |