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Terminated

Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

FDA Recall Z-1021-2011 · Posted 2011-02-02

Recalling FirmVital Images, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-08-23
Date Terminated2012-11-06
Product Quantity178

Reason for Recall

There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data

Firm Action

The firm, Vital Images, Inc,., sent a "Urgent Software Alert" letter dated August 23, 2010 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to not use the PET/CT fusion functionality until the software updates are provided and to re-examine any past results. If you have any questions or comments, contact Customer Support at [email protected] or at 1-800-208-3005.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: USA including states of: AK, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, PA, SC, TN, TX VA, WV, WI, and WY; and countries of: AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, and ITALY.AUSTRALIA, HONG KONG, UNITED KINGDOM, NETHERLANDS, FRANCE, BELGIUM, CANADA, CHINA, AUSTRALIA, SWITZERLAND, ITALY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071362VITAL CONNECT 4.1Vital Images, Inc. · 2007-05-30K062154VITAL CONNECT 4.0Vital Images, Inc. · 2006-08-10

Official Source

View FDA Recall →

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

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