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
Hazard
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
What You Should Do
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
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