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U.S. Department of Health and Human Services

Class 3 Device Recall EVMS (Enterprise Visual Medical System Software)

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 Class 3 Recall
EVMS (Enterprise Visual Medical System Software)
see related information
Date Posted May 28, 2008
Recall Status1 Terminated on June 11, 2009
Recall Number Z-1644-2008
Recall Event ID 47526
Premarket Notification
510(K) Number
K053281 
Product Classification System, Image Processing, Radiological - Product Code LLZ
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.
Code Information Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1.
Recalling Firm/
Manufacturer
Emageon
900 Walnut Ridge Dr
P.O. Box 950
Hartland, Wisconsin 53029-0950
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 99
Distribution Nationwide Distribution including states of: MI, WI, CA, MN, AZ, CO, MN, MD, DC, MO, TX, IL, GA, FL, WI, SC, PA, NY, KS, TN, AL and OK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = EMAGEON INC.
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