Recall Z-1600-2010 ยท LLZ System, Image Processing, Radiological
Vital Images, Inc.
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
| Date | May 13, 2010 (initiated Feb 23, 2010) |
| Status | Terminated |
| Reason | Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2. because incorrect measurements may result. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005. |
| Root cause | Software design |
| Action | Consignees were sent a Vital "Urgent Medical Device Software Recall Notice" letter dated 23 February 2010. The letter was addressed to "Dear Customer." The letter described the problem, product affected and provided recommendation to their customers. Questions or comments are directed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005. |
| Quantity | 95 |
| Distribution | AZ, AR, CA, COT, CT, FL, GA, IN, IA, KY, LA, MD, MA, MI, MN, NV, NJ, NY, ND, OH, PA, SC, TX, VA, WA, WV, WI. AUSTRALIA, SPAIN, FRANCE, BELGIUM, NETHERLANDS, PERU, NIGERIA, SWEDEN, CANADA, SWITZERLAND, EGYPT, CHINA, GERMANY, PANAMA, TAIWAN, HONG KONG, VENEZUELA, SOUTH AFRICA, CHILE, MEXICO, KOREA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091498 | VITREA ENDOVASCULAR STENT PLANNING SOFTWARE Vital Images, Inc., Jun 5, 2009 |