Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise S
FDA device recall Z-0388-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- Reason for recall
- Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
- Action taken
- Vital Images, Inc. sent an URGENT DEVICE RECALL letter dated November 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to inform all potential users of the issues. Customers were to be contacted by their Service Account Manager to discuss and schedule resolutions. For questions customers were to contact Vital Images Customer Support with any questions toll free at 1-800-208-3005, in Europe +31 (0) 70 4135801, in Asia t +86 10 8588 1800, or online at support@vitalimages.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 338 (233 US)
- Distribution
- Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK OR, PA, SC, SD, TN, TX, UT, VT, VA
- Date initiated
- 2011-11-11
- Date posted
- 2012-01-11
- Date terminated
- 2013-12-03
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITREA VERSION 4.0 (K071331) | Vital Images, Inc. | 2007-05-25 |
| VITREA, VERSION 3.9 (K061624) | Vital Images, Inc. | 2006-06-27 |