{ "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": [ { "status": "Terminated", "city": "Waukesha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "65029", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "address_2": "", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Visit", "distribution_pattern": "Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela", "recall_number": "Z-1318-2013", "product_description": "GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.", "product_quantity": "713", "reason_for_recall": "While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.", "recall_initiation_date": "20111220", "center_classification_date": "20130514", "termination_date": "20140313", "report_date": "20130522", "code_info": "Serial # 00000520055BU5 00000009C20026 00000007C20159 00000007C20161 00000008C2M001 0000009C2M0068 00000007C20152 00000519147BU3 00000466843BU0 00000489559BU5 00000009C20099 00000009C20109 00000466851BU3 00000008C20053 00000519174BU7 00000008C20312 00000008C20210 00000007C20391 00000007C20039 00000007C20322 00000008C20079 00000478341BU1 00000536797BU4 00000009C20075 00000008C20214 00000009C20017 00000498702BU0 00000498705BU3 00000007C20324 00000008C20221 00000465840BU7 00000007C20198 00000007C20183 00000536791BU7 00000008C20224 00000008C20227 00000478340BU3 0000009C2M0119 0000009C2M0127 00000532669BU9 00000007C20117 00000009C20036 00000520074BU6 00000007C20012 00000008C20084 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