{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "123687", "product_res_number": "Z-0529-2014", "event_date_initiated": "2013-11-07", "event_date_posted": "2014-01-09", "recall_status": "Terminated", "event_date_terminated": "2015-01-27", "res_event_number": "66833", "product_code": "MQB", "product_description": "EOS System X- ray beam\n\nDigital radiography system used in general radiographic examinations.", "code_info": "EOS System", "firm_fei_number": "3006165260", "recalling_firm": "EOS Imaging", "address_1": "10 rue Mercoeur 4 Ieme Etage 10 rue Mercoeur 4 Ieme", "address_2": "Etage", "city": "Paris France", "country": "France", "reason_for_recall": "EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of\nthe X-ray beam operated by the EOS system during the X-ray acquisition.", "root_cause_description": "Device Design", "action": "CDRH approves the following conditions for EOS Imaging SA:\n\n1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons:\na. It does not provide a statement that all repairs will be made without\ncharge (21 CFR 1003.21(3)).\nb. It does not provide instructions, with respect to the use of the product pending the correction of the defect (21 CFR 1003.21(1). Specifically, the letter should include directions for the user to determine if the collimation defect is currently present in their system, which would initiate immediate correction, rather than at the next semi-annual service.\n2. The customer notification letter will be sent in the manner required by 21\nCFR 1003.21(b).\n3. The repairs outlined are to be completed by July 1, 2014. All systems under service contracts (which includes semi-annual service) would be visited between receipt of this letter and July 1, 2014. All repairs, including those to systems which are not under service contracts, are also expected to be completed by July 1, 2014.\nEOS may proceed with implementation of the CAP (subject to the conditions noted above. The customer notification letter may be sent out immediately upon addressing the above deficiencies. However, it is suggested that you provide a copy of the revised letter to FDA for approval prior to issuance.\n\nFor further questions please call (678) 564-5400.", "product_quantity": "22 EOS systems are installed in US", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K153318", "K081624", "K140251", "K212105", "K162178", "K191939", "K232058", "K172124", "K111312", "K221714", "K031447", "K191645", "K131211", "K243734", "K140551", "K061538", "K003256", "K222855", "K202995", "K113630", "K214030", "K052136", "K250211", "K101289", "K081963", "K111548", "K122919", "K063710", "K130883", "K201796", "K140646", "K153312", "K181526", "K001499", "K181565", "K053634", "K180332", "K102474", "K182348", "K020635", "K050810", "K081648", "K133693", "K122928", "K141736", "K172681", "K071162", "K180976", "K133120", "K031633", "K122736", "K203159", "K992794", "K111098", "K090625", "K182550", "K050718", "K171270", "K201591", "K102587", "K102619", "K171716", "K213307", 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