Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
- Company
- Vital Images, Inc.
- Recall Initiated
- February 23, 2010
- Posted
- May 13, 2010
- Terminated
- June 7, 2012
- Recall Number
- Z-1600-2010
- Quantity
- 95
- Firm Location
- Plymouth, MN
Reason for Recall
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.
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, COLOMBIA.
Lot / Code Info
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2
Root Cause
Software design
Action Taken
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.