Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and V
FDA device recall Z-1144-2013 · posted 2013-04-18 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- Reason for recall
- Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.
- Action taken
- Vital Images sent an Urgent Field Safety Notice dated March 15, 2013, to all affected consignees. The letter described the problem and the product affected by the recall. Letter provided a series of steps to follow which included to cease use of the device and to send the signed enclosed Effectiveness Check form to fieldnotices@vitalimages.com or fax to 1-952-540-3717. For questions customers were instructed to call Customer Support at 1-800-208-3005. For questions regarding this recall call 952-487-9500.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 102
- Distribution
- Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NE
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-18
- Date terminated
- 2015-02-27
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE (K052632) | Vital Images, Inc. | 2005-12-15 |
| VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM (K043333) | Vital Images, Inc. | 2004-12-15 |