{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167170", "product_res_number": "Z-3191-2018", "event_date_initiated": "2016-11-18", "event_date_posted": "2018-09-18", "recall_status": "Open, Classified", "res_event_number": "80981", "product_code": "KPR", "k_numbers": [ "K052943" ], "product_description": "ddR Formula B X-ray System, Model ddR Formula B\n\n X-ray system used for imaging", "code_info": "Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008   Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008 & 1602004", "firm_fei_number": "1000469975", "recalling_firm": "Swissray Medical", "address_1": "Hohenrainstrasse 61 61 hohenrainstrasse", "city": "Hochdorf", "country": "Switzerland", "reason_for_recall": "Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.", "root_cause_description": "Device Design", "action": "The firm, Swissray Medical, issued official communication to customers as a Action Notification Report/work Instructions on November 18 2016. The Work Instructions state the affected devices, the problem symptoms, causes of the problem, remedy, any tools required, and the step-by-step corrective actions. The manufacturer, Swissray Medical AG, distributed the Work Instructions for the FCO and the Action Notification Report Form to all distributors and service entities who would be performing corrective actions in the field. The Swissray Field Engineer then presented the Report to the customer (end user facility) and communicated with the customer in-person while performing the corrective action on-site. When corrective actions were completed, both the customer and service personnel then sign the Report to confirm that the customer was informed about the corrective action and that corrective action was completed. The Report Form states the title and unique designation of the corrective action, whether it was mandatory by the manufacturer or was an optional product improvement, and the unique document ID number of the Work Instructions for the FCO. \n\nThe customers were instructed to Complete the FCO Action Notification Report and send to:\nSwissray Medical AG\nexpert Center\nTurbistrasse 25-27\nCH-6280 Hochdorf\nSwitzerland\nOr scan and email to service@swissray.com with FCO in the subject line.\n\nIf you have any questions, contact QA/RA Coordinator at 908-372-6408 or email: Deniz.Kortan@swissray.com.", "product_quantity": "27 devices in US", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. 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