Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
FDA Recall Z-1600-2010 · Posted 2010-05-13
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Recalling FirmVital Images, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-02-23
Date Terminated2012-06-07
Product Quantity95
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 [email protected] or at 1-800-208-3005.
Firm 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 [email protected] or at 1-800-208-3005.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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