{ "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": 3 } }, "results": [ { "cfres_id": "221184", "product_res_number": "Z-2726-2026", "event_date_initiated": "2026-06-05", "event_date_posted": "2026-07-13", "recall_status": "Open, Classified", "res_event_number": "99279", "product_code": "IZL", "k_numbers": [ "K103476", "K142383" ], "product_description": "Optima XR200amx, Mobile Digital-Ready Radiographic System", "code_info": "UDI-DI: 00840682115278;\nSystem IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100", "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 that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.", "root_cause_description": "Process control", "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 6/5/26 was sent to customers.\n\nActions to be taken by Customer/User\nPending corrections from GE HealthCare, you can continue to use the system by following the instructions below:\nPerform a check of your device prior to each patient exam to look for the following behaviors:\n\"Column vertical movement requires increased effort.\n\"Column has change in resistance (i.e. movement is not smooth) during vertical movement.\n\"Column makes abnormal noises during vertical movement.\nIf any are observed, DO NOT use the device and call GE HealthCare Service Immediately.\nPlease ensure all potential users in your facility are made aware of this safety notification and the recommended actions.\nPlease retain this document for your records.\nPlease complete and return the attached acknowledgement form electronically via FMI 10967 Digital Response Form or print, fill out manually, scan, and email to Recall.10967@gehealthcare.com.", "product_quantity": "4 units", "distribution_pattern": "Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.", "openfda": { "k_number": [ "K953292", "K790512", "K240284", "K911841", "K873982", "K203667", "K211423", "K850678", "K242515", "K931279", "K981466", "K090655", "K955036", "K222951", "K902984", "K082627", "K141885", "K790673", "K063262", "K241996", "K103597", "K780999", "K141539", "K781030", "K253185", "K043062", "K992229", "K781982", "K930699", "K162990", "K191451", "K042866", "K833239", "K120062", "K941363", "K201124", "K243473", "K810276", "K843192", "K200637", "K070634", "K090322", "K012379", "K001517", "K080701", "K143494", "K760741", "K251710", "K902610", "K210479", "K122697", "K802047", "K923359", "K930049", "K071015", "K122298", "K213462", "K253244", "K253058", "K040046", "K192011", "K191813", "K030494", "K111725", 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"1000120772", "3014209556", "3009001657", "3008044777", "1418484", "3017375271", "3023344919", "3002707445" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }