Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and
FDA device recall Z-1181-2013 · posted 2013-04-26 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- Reason for recall
- Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
- Action taken
- Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, support@vitalimages.com.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1,978
- Distribution
- Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA,
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-26
- Date terminated
- 2015-04-08
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITREAADVANCED (K121213) | Vital Images, Inc. | 2012-11-02 |
| VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE (K032748) | Vital Images, Inc. | 2003-10-29 |