{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Waukesha", "address_1": "3000 N Grandview Blvd", "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. 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GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.", "state": "WI", "product_description": "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.", "report_date": "20120822", "classification": "Class II", "openfda": {}, "recalling_firm": "GE Healthcare, LLC", "recall_number": "Z-2203-2012", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "61614", "termination_date": "20121211", "more_code_info": "", "recall_initiation_date": "20120524", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }