| Class 3 Device Recall EVMS (Enterprise Visual Medical System Software) |  |
Date Initiated by Firm | January 01, 2008 |
Date Posted | May 28, 2008 |
Recall Status1 |
Terminated 3 on June 11, 2009 |
Recall Number | Z-1644-2008 |
Recall Event ID |
47526 |
510(K)Number | K053281 |
Product Classification |
Picture archiving and communications system - Product Code LLZ
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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 WI 53029-0950
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For Additional Information Contact | 262-367-0700 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LLZ
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