{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199303", "product_res_number": "Z-1414-2023", "event_date_initiated": "2023-03-08", "event_date_posted": "2023-04-19", "recall_status": "Open, Classified", "res_event_number": "91959", "product_code": "IZL", "k_numbers": [ "K222353" ], "product_description": "Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System", "code_info": "UDI-DI: 08806088582412\nGM85 systems 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08806088582412)", "firm_fei_number": "3004938766", "recalling_firm": "NeuroLogica Corporation", "address_1": "14 Electronics Ave", "city": "Danvers", "state": "MA", "postal_code": "01923-1011", "additional_info_contact": "SAME\n978-564-8500", "reason_for_recall": "Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm", "root_cause_description": "Device Design", "action": "NeuroLogica (Importer)for Samsung Electronics GM85 digital x-ray system issued Urgent Medical Device Correction letter issued 3/8/23 via email. Letter states reason for recall, health risk and action to take:\n\nPlease identify the system label and confirm whether or not your device is one of those affected by this FSN. The list of affected serial numbers is provided in the Appendix.\nSamsung Electronics will undertake the voluntary corrective action considering the possibility of potential bodily harm due to the fall of the arm.\nService engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field will be completed by September 2023.\n\nUsers may continue to use the GM85 system.\nThis notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\nPlease transfer this notice to other organizations on which this action has an impact.\nPlease maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action", "product_quantity": "935 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K222896", "K802047", "K894643", "K203667", "K220175", "K251443", "K782155", "K171119", "K921116", "K242515", "K001517", "K213405", "K173187", "K932353", "K240009", "K182207", "K150097", "K253185", "K912400", "K874840", "K173299", "K972204", "K042866", "K873982", "K210982", "K002685", "K945707", "K781705", "K203658", "K843192", "K090322", "K161345", "K043002", 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