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Terminated

GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.

FDA Recall Z-2203-2012 · Posted 2012-08-13

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-05-24
Date Terminated2012-12-11
Product Quantity1055

Reason for Recall

GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 23, 2012 to consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the affected product details, safety issue, safety instructions and product correction. For more information on this topic, contact a GE Application Specialist or your GE Field Service representative. For questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US (nationwide) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA, PR, SC, SD, TN, TX, VA, WA, WV, WI and the countries of YUGOSLAVIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SA¿DE ARABIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF MALTA, PORTUGAL, POLAND, PHILIPPINES, NORWAY, NIGERIA, NEW ZEALAND, MEXICO, KOREA, KENYA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HUNGRY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052995ADVANTAGE WORKSTATION 4.3.GE Healthcare · 2005-11-08K020483ADVANTAGE WORKSTATION 4.1GE Medical Systems · 2002-02-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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