{ "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": "198578", "product_res_number": "Z-1206-2023", "event_date_initiated": "2023-01-30", "event_date_posted": "2023-03-02", "recall_status": "Open, Classified", "res_event_number": "91698", "product_code": "KPR", "k_numbers": [ "K201373" ], "product_description": "DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. \nCATALOG #(s):\n8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F\n8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F\n8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F\n8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F\n\nNote: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).", "code_info": "UDI:\n60889978621613 (Rayco)\n60889978624188 (1049)\n\nUS Serial Numbers:\nSP0763\n50066\n50082\n50089\n50135\n50145\n50143\n50140D\n50144\n\nOUS serial numbers:\nSP0819\nSP0687G2\nSP0726\nSP0746\nSP0834\nSP0837\nS0001\nS0170\nS0698G2\n1085\nFS0564\nS0578\nS0744\nSP0903\nSP0600\nSP1035\nSP0930\nSP1007\nSP1037\nSP0772\nS0934G2\nS0639G2\nS1020G2\nS0118\nS0135\nS0134\nS0165\nS0167\nS0168\nS0181\nS0800G2\nS0784G2\nS0811G2\nS0832G2\nS0826G2\nS0822G2\nS1038G2\nS0678G2\nS0619G2\nS0636G2\nS0641G2\nS0643G2\nS0701G2\nS0738G2\nS0758G2\nS0760G2\nS0673G2\nS0785G2\nS0842G2\nS0860G2\nS0863G2\nS0888G2\nS0973G2\nS1105G2\nS1048G2\nS1073G2\nS1004G2\nS1110G2\nS0791G2\nS0941G2\n\nSP0900\nS0625", "firm_fei_number": "1317307", "recalling_firm": "Carestream Health, Inc.", "address_1": "1049 W Ridge Rd", "city": "Rochester", "state": "NY", "postal_code": "14615-2731", "additional_info_contact": "SAME\n585-627-8886", "reason_for_recall": "After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement\nunexpectedly to a certain distance which could potentially result in a injury", "root_cause_description": "Software design", "action": "Carestream issued Urgent Medical Device Correction Letter to Director of Radiology, Chief Radiology Administrator and DRX-Compass/DR-FIT X-ray System Administrators (US) consignees on 1/30/23. Letter states reason for recall, health risk and action to take:\nDo not use the Z-Axis Motorized button on the Tube Head Display at this time. Use the Brake Release buttons (Items 5 or 8) to manually move the OTC in the Z-Axis.\n\" Press any E-stop button to stop unexpected movement immediately.\n\" A Service Representative will install a Firmware correction.\nAction to be taken:\nA Carestream Service Engineer or Carestream Health Authorized Representative will contact your site and setup a service call to inspect your device and install a new firmware version.\nFor your convenience, a Notification Acknowledgement form has been provided with this letter. Please read and complete the information within 5 working days.\nRemit the completed form by e-mail to: postmarketra@carestream.com.\nQuestions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream S\nvice support number", "product_quantity": "72 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.", "openfda": { "k_number": [ "K941592", "K803130", "K123098", "K912517", "K880982", "K982955", "K072867", "K910757", "K191879", "K771051", "K061595", "K140683", "K071409", "K233381", "K941931", "K781983", "K132934", "K151219", "K790740", "K071546", "K800564", "K011111", "K883160", "K080655", "K201373", "K193089", "K050151", "K163115", "K192453", "K904145", "K974863", "K803049", "K150506", "K203537", "K936087", "K790069", "K123105", "K953832", "K984111", "K023008", "K231892", "K810973", "K033345", "K110849", "K933023", "K183541", "K883834", "K212186", 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