Emageon EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029.
Brand
Emageon
Lot Codes / Batch Numbers
Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1.
Products Sold
Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1.
Emageon is recalling EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: due to Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.
Recommended Action
Per FDA guidance
Consignees were notified by Urgent Device Correction letters that were sent on 1/9/08 and 1/18/08. The letters instructed users not to use the standard uptake value in EVMS for diagnostic interpretation when viewing PET studies unless they received service bulletin 445, 446 or 7.0.1. Users were also instructed to replace pages in the user's guide with the pages provided and to affix the enclosed warning sticker on all workstations. Users will be contacted by the recalling firm to schedule a software patch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026