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Terminated

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.

FDA Recall Z-0388-2012 · Posted 2012-01-11

Recalling FirmVital Images, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-11-11
Date Terminated2013-12-03
Product Quantity338 (233 US)

Reason for Recall

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.

Firm 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 [email protected].

Root Cause

Software design

Distribution Pattern

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, SLOVENIA, GERMANY, NETHERLANDS, BELGIUM, PAKISTAN, BRAZIL, ARGENTINA, SWEDEN, QATAR, CHINA, FINLAND, ITALY, DENMARK, PORTUGAL, REPUBLIC OF KOREA, SPAIN, and CANADA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071331VITREA VERSION 4.0Vital Images, Inc. · 2007-05-25K061624VITREA, VERSION 3.9Vital Images, Inc. · 2006-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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