| Class 2 Device Recall GE Healthcare, AW Server. | |
Date Initiated by Firm | June 28, 2012 |
Date Posted | April 17, 2013 |
Recall Status1 |
Terminated 3 on February 04, 2014 |
Recall Number | Z-1137-2013 |
Recall Event ID |
64900 |
510(K)Number | K081985 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | GE Healthcare, AW Server.
Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. |
Code Information |
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00000L8B2FAE2A 00000H12118001 00000P10312010 00000V11136003 00000B12048009 00000Q11340002 00000E11301001 00000F11206003 000001010024GS 00000B12048007 00000Y11013001 00000Z10335002 000001010040GS 00000B12048008 00000Q11340001 0000AM11360001 00000M12067007 00000P10347005 00000P11244008 000001010045GS 0000AM11360002 0000AX11314004 00000Q11333002 00000B12002006 00000A11096009 00000P10347010 0000AB11054003 00000Y11013009 00000M11284005 0000AD11104004 0000AD11104005 00000L7B3745A8 USE152PED2 000001010023GS
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Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server.
After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe |
FDA Determined Cause 2 | Software design |
Action | GE Healthcare sent an "Important Product Information" letter dated June 27, 2012. The letter was addressed to Hospital Administrators , Radiology Managers and Risk Managers. The letter described the Subject, Instructions and Affected Product Details. GE Healthcare will correct all affected product by providing a software upgrade at no cost. For questions call: US 800-437-1171, Japan 0120-055-919, and/or local GE Healthcare Service Representative. |
Quantity in Commerce | 429 |
Distribution | Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES. |
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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