{ "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. 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"recalling_firm": "Hitachi Medical Systems America Inc", "address_1": "1959 Summit Commerce Park", "city": "Twinsburg", "state": "OH", "postal_code": "44087-2371", "additional_info_contact": "Douglas J. Thistlethwaite\n330-425-1313 Ext. 3720", "reason_for_recall": "The strength of the arm mounting mechanism was insufficient and had to be redesigned.", "root_cause_description": "Device Design", "action": "An Urgent: Device Correction Notice was sent via overnight carrier on 5/5/17. The Notice identified the affected product and problem. The firm will replace the Monitor Arm to correct the issue at no cost to the customer. If the problem occurs, customers are to call 800-800-4925 for immediate service. Hitachi Service will update the hardware at each site. Customers can contact recalls@hitachihealthcare.com with questions, comments, or requests regarding the Notice.", "product_quantity": "77", "distribution_pattern": "Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.", "openfda": { "k_number": [ "K143601", "K220882", "K162045", "K113381", "K073297", "K023720", "K012369", "K240053", "K153626", "K043588", "K220851", "K131973", "K160442", "K943863", "K072365", "K171070", "K926351", "K121729", "K180374", "K163443", "K021984", "K162243", "K941652", "K241582", "K241671", "K110943", "K133329", "K063130", "K173058", "K103397", "K003986", "K251481", "K222365", "K152369", "K102104", "K223017", "K252018", "K173265", "K120060", "K122825", "K142511", "K133277", "K152052", "K192226", "K251110", "K243620", "K153085", "K982498", "K052042", "K220983", "K021497", "K261288", "K231659", "K180599", "K162329", "K113690", "K243299", "K181783", "K230346", "K241432", "K810133", "K163505", "K042055", 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