Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Sui
FDA device recall Z-0520-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Vital Images, Inc.
- Reason for recall
- Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not up
- Action taken
- Customers were notified via telephone (11/7 -11/8/2007) and issued an Urgent Medical Device recall notification letter on 11/8/07. The letter described the problem and product involved. The letter also informed customers they they will provide a free software patch within the next 6-8 weeks.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 18
- Distribution
- Worldwide-USA including states of SC, MO, MI, WI, NY, FL, CO, CA, PA, and WA, and countries of England and The Netherlands
- Date initiated
- 2007-11-08
- Date posted
- 2008-01-31
- Date terminated
- 2011-12-17
- Location
- Plymouth, MN
Monitor recalls programmatically
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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 |