Recall Z-0388-2012 ยท LLZ System, Image Processing, Radiological
Vital Images, Inc.
Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.
| Date | Jan 11, 2012 (initiated Nov 11, 2011) |
| Status | Terminated |
| Reason | Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions. |
| Root cause | Software design |
| Action | Vital Images, Inc. sent an URGENT DEVICE RECALL letter dated November 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to inform all potential users of the issues. Customers were to be contacted by their Service Account Manager to discuss and schedule resolutions. For questions customers were to contact Vital Images Customer Support with any questions toll free at 1-800-208-3005, in Europe +31 (0) 70 4135801, in Asia t +86 10 8588 1800, or online at support@vitalimages.com. |
| Quantity | 338 (233 US) |
| Distribution | Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of IRELAND, FRANCE, UNITED KINGDOM, SWITZERLAND, AUSTRALIA, S |
| FDA record | Open on fda.gov |