{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "169713", "product_res_number": "Z-0697-2019", "event_date_initiated": "2018-11-14", "event_date_posted": "2019-01-08", "recall_status": "Terminated", "event_date_terminated": "2021-09-01", "res_event_number": "81749", "product_code": "MQB", "k_numbers": [ "K050718" ], "product_description": "ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)\n\nThe ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.", "code_info": "Serial Numbers: S403088, S403089, S403165", "firm_fei_number": "3002143662", "recalling_firm": "Swissray Medical AG", "address_1": "Turbistrasse 25-27 25-27 turbistrasse", "city": "Hochdorf", "country": "Switzerland", "additional_info_contact": "Deniz Kortan\n908-372-6408", "reason_for_recall": "A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope\nof the lifting column, which is designed to take the load, can break without triggering the safety\nlock. This can lead to overloading of the safety cable, which is not designed to permanently carry\nthe load of the lifting column or continuously move under load. This could cause material\nfatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops\nunexpectedly, patients and users may be seriously injured.", "root_cause_description": "Component design/selection", "action": "A component of the device was recalled by a supplier (Siemens AG/Siemens Healthcare GmbH), as a result, Swissray Medical AG, sent an \"Important Warning / Important Safety Notice\" letters dated 11/14/18 to its customers. The letter described the product, problem and actions to be taken. The firm stated safety related retrofits are available for installation to eliminate risk to patients and users.The retrofit aims to completely correct the problem. The customers were instructed to do the following: To mitigate risk to patients and users until the retrofit modification is implemented, users are strongly advised not to move the column up/down directly above the patient, but to instead first perform vertical movement next to the patient, and then horizontally position over the patient at a fixed height.\n\nPlease ensure that all your users who own the affected products and others who are aware or them receive the safety-related information provided with this safety notice, and comply with the recommendations contained therein.\n\nIf you have any questions, contact US Agent of Swissray Medical AG, QA/RA Coordinator at 908-372-6408 or email: Deniz.Kortan@swissray.com.", "product_quantity": "3", "distribution_pattern": "Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.", "openfda": { "k_number": [ "K202722", "K210619", "K222661", "K042023", "K103348", "K232753", 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"3002807092", "3013688559", "3002175190", "3005254598", "3013599033", "3015223550", "3023546785", "3002808382" ], "device_name": "Solid State X-Ray Imager (Flat Panel/Digital Imager)", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }