Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process
FDA device recall Z-1021-2011 · posted 2011-02-02 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- 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
- Action taken
- 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 support@vitalimages.com or at 1-800-208-3005.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 178
- Distribution
- 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 countrie
- Date initiated
- 2010-08-23
- Date posted
- 2011-02-02
- Date terminated
- 2012-11-06
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITAL CONNECT 4.1 (K071362) | Vital Images, Inc. | 2007-05-30 |
| VITAL CONNECT 4.0 (K062154) | Vital Images, Inc. | 2006-08-10 |