{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "110040", "product_res_number": "Z-0264-2013", "event_date_initiated": "2011-10-28", "event_date_posted": "2012-11-08", "recall_status": "Terminated", "event_date_terminated": "2016-07-26", "res_event_number": "62271", "product_code": "IZL", "k_numbers": [ "K090268" ], "product_description": "0.7/1.2JG326D-265\n\n\n Product Usage:\nThe device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.", "code_info": "MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058  MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043", "firm_fei_number": "1000125362", "recalling_firm": "Shimadzu Medical Systems", "address_1": "20101 S Vermont Ave", "city": "Torrance", "state": "CA", "postal_code": "90502-1328", "additional_info_contact": "310-217-8855 Ext. 139", "reason_for_recall": "Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.", "root_cause_description": "Nonconforming Material/Component", "action": "Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.", "product_quantity": "5 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K182639", "K212654", "K182207", "K103597", "K222339", "K240284", "K972204", "K201340", "K222951", "K231577", "K893637", "K072392", "K811082", "K143494", "K221417", "K200637", "K955036", "K001517", "K012663", "K220700", "K082627", "K251710", "K790451", "K092713", "K120062", "K181626", "K790512", "K163063", "K220678", "K191813", "K111912", "K242015", "K790393", "K953404", "K162990", "K250597", "K251443", "K955095", "K843192", "K912400", "K873982", "K080701", "K813128", "K891143", "K200976", "K052721", "K222353", "K790392", "K780313", "K781975", "K781982", "K061685", "K781705", "K002685", "K781590", "K143537", "K242515", "K241980", "K790673", "K052341", "K121410", "K932354", "K781676", 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"K250750", "K122697", "K191025", "K173924", "K043002", "K192011", "K781030", "K862118", "K010304", "K941363", "K211423", "K171119", "K253244", "K944442", "K934818", "K212144", "K972365", "K030494", "K930699", "K052897", "K833239", "K071015", "K042866", "K810276", "K020436", "K220175", "K911841", "K022337", "K150097", "K244049", "K213568", "K101517", "K200726", "K100449", "K891142", "K141885", "K210479", "K140723", "K781425", "K924798", "K250976", "K043062", "K781276", "K212515", "K253185", "K760741", "K251223", "K932355", "K070634", "K862452", "K210982", "K790511", "K240841", "K183292", "K041763", "K780947", "K062472", "K931483", "K170607", "K032280", "K201124", "K211473", "K260236", "K883092", "K203667", "K780999", "K193535", "K792665", "K103522", "K221081", "K241996", "K042368", "K192936", "K182234", "K850678", "K191884", "K173018", "K931200", "K171353", "K213462", "K103476", "K203782", "K945707" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", 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