{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113032", "product_res_number": "Z-0449-2013", "event_date_initiated": "2012-08-01", "event_date_posted": "2012-11-29", "recall_status": "Terminated", "event_date_terminated": "2013-01-10", "res_event_number": "63212", "product_code": "IZL", "product_description": "GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System\n\nThe GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx,\nOptima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).", "code_info": "Model No - 5555000-6", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-513-4122", "reason_for_recall": "GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.", "root_cause_description": "Radiation Control for Health and Safety Act", "action": "GE Healthcare will without charge remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication through a GE Healthcare field engineer site visit. \n\nField Modification Instructions (FMI) 10868 describes the rework plan the GEHC Engineers will make to the imaging system compliant with the applicable performance standard.\n\nThis CAP appears to adequately address the problem and is hereby approved.\n\nCall Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.", "product_quantity": "217 total Installed in the US", "distribution_pattern": "Nationwide distribution", "openfda": { "k_number": [ "K210982", "K121410", "K813128", "K790392", "K932355", "K012379", "K241505", "K923359", "K032628", "K203782", "K182317", "K202353", "K981466", "K022337", "K173602", "K781030", "K243864", "K234108", "K874840", "K173924", "K944442", "K790451", "K211473", "K151038", "K213405", "K141539", "K202350", "K222258", "K020436", "K833226", "K833239", "K932106", "K122697", "K955095", "K955036", "K211423", "K790393", "K111912", "K241996", "K902984", "K232185", "K973712", "K781705", "K090268", "K221417", "K921425", "K260085", "K912400", "K782155", "K182234", "K071015", "K171353", "K111725", "K251223", "K042361", "K170755", "K141895", "K040046", "K253244", "K043002", "K100400", "K912323", "K781590", "K233678", "K213462", 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