{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "220070", "product_res_number": "Z-2314-2026", "event_date_initiated": "2026-04-20", "event_date_posted": "2026-06-05", "recall_status": "Open, Classified", "res_event_number": "98880", "product_code": "OWB", "k_numbers": [ "K232344" ], "product_description": "Allia IGS 3 Pulse angiographic X-ray system", "code_info": "UDI-DI: 00195278719577;\nSerial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.", "root_cause_description": "Device Design", "action": "An URGENT MEDICAL DEVICE CORRECTION dated 4/20/26 was sent to customers.\n\nActions to be taken by Customer/User\nYou can continue to use your system.\n\nAs a reminder, qualified service personnel must follow the Service Manual applicable to your system and use the appropriate personal protective equipment (PPE) for electrical hazards when performing any activity inside the cabinet while power is ON.\n\nIf any abnormal condition is observed on the Iris Power Cable during servicing, such as loose or visibly exposed wires, qualified service personnel must follow the Electrical Lockout/Tagout Procedure as described in Service Manual.\n\nPlease ensure that all potential users and service personnel in your facility are made aware of this safety notification and the recommended actions and post this letter in a visible location near the C-FRT cabinet.\n\nPlease retain this document for your records.\n\nPlease complete and return the attached acknowledgement form electronically via FMI 18014 Digital Response Form or print, fill out manually, scan, and email to\nrecall.18014@gehealthcare.com.", "product_quantity": "9 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K253584", "K170752", "K170144", "K192182", "K170909", "K142126", "K970734", "K052412", "K180473", "K232420", "K161839", "K051064", "K210309", "K250010", "K251523", "K113403", "K122644", "K062623", "K093688", "K121444", "K201743", "K181943", "K024200", "K183040", "K070123", "K232298", "K233200", "K083545", "K912448", "K062647", "K172646", "K162148", "K021049", "K061953", "K142736", "K251199", "K022322", "K253670", "K190064", "K251602", "K961374", "K993037", "K100102", "K233748", "K153147", "K151904", "K200887", 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