Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.
FDA device recall Z-0186-2013 · posted 2012-11-01 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- Reason for recall
- Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
- Action taken
- Vital Images sent an "URGENT DEVICE CORRECTION" letter dated August 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter gave advise on how to resolve the two issues and advised consignees to immediately inform all potential users. Contact Customer Support at 1-800-208-3005 for questions regarding the notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2088 (1133 USA)
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLO
- Date initiated
- 2012-08-13
- Date posted
- 2012-11-01
- Date terminated
- 2015-03-25
- Location
- Plymouth, 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 3.4 MEDICAL IMAGE PROCESSING SOFTWARE (K032748) | Vital Images, Inc. | 2003-10-29 |