{ "format": "devicerts.device.v1", "cite_as": "Multitom Rax 10860700, Siemens Healthcare GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/multitom-rax-10860700 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/multitom-rax-10860700", "json_url": "https://devicerts.com/devices/multitom-rax-10860700.json", "markdown_url": "https://devicerts.com/devices/multitom-rax-10860700.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-11-12", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/multitom-rax-10860700", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "Multitom Rax 10860700", "registry_name": "Multitom Rax 10860700", "url": "https://devicerts.com/devices/multitom-rax-10860700", "manufacturer": { "name": "Siemens Healthcare GmbH", "url": "https://devicerts.com/manufacturers/siemens-healthcare-gmbh", "country": "Germany", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIb", "system": "EU MDR" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "10860700", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "04056869009179", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "0405686901995WU", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K152928", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K173639", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K212212", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K221281", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "OWB", "JAK", "JAA" ], "emdn": [ { "code": "Z11039009", "term": "FLUOROSCOPY DEVICES" } ], "gmdn": [ { "code": "37679", "term": "Stationary general-purpose fluoroscopic x-ray system, digital" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDR", "number": "0405686901995WU", "number_label": "Basic UDI-DI", "device_udi_di": "04056869009179", "date": "2026-05-28", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K221281", "number_label": null, "device_udi_di": null, "date": "2022-11-17", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K212212", "number_label": null, "device_udi_di": null, "date": "2022-02-18", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K173639", "number_label": null, "device_udi_di": null, "date": "2018-04-02", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "04056869009179", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-24", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K152928", "number_label": null, "device_udi_di": null, "date": "2015-11-13", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-0999-2026", "classification": "Class II", "status": "ongoing", "initiated": "2025-12-05", "reason": "A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max\nsystems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When\nswitching quickly between organ programs (OGPs) the collimation may be incorrect.", "applies": "this device", "via": "K173639" }, { "number": "Z-1982-2025", "classification": "Class II", "status": "ongoing", "initiated": "2025-06-04", "reason": "A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.", "applies": "this device", "via": "K173639" }, { "number": "Z-1981-2025", "classification": "Class II", "status": "ongoing", "initiated": "2025-06-04", "reason": "A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.", "applies": "this device", "via": "K173639" }, { "number": "Z-2527-2024", "classification": "Class II", "status": "ongoing", "initiated": "2024-07-02", "reason": "The support arm may unintentionally lower resulting in injury to persons when they are under the\ndisplay ceiling/wall suspension when positioning the displays", "applies": "this device", "via": "K173639" }, { "number": "Z-2525-2024", "classification": "Class II", "status": "ongoing", "initiated": "2024-07-02", "reason": "The support arm may unintentionally lower resulting in injury to persons when they are under the\ndisplay ceiling/wall suspension when positioning the displays", "applies": "this device", "via": "K173639" }, { "number": "Z-2526-2024", "classification": "Class II", "status": "ongoing", "initiated": "2024-07-02", "reason": "The support arm may unintentionally lower resulting in injury to persons when they are under the\ndisplay ceiling/wall suspension when positioning the displays", "applies": "this device", "via": "K173639" }, { "number": "Z-2528-2024", "classification": "Class II", "status": "ongoing", "initiated": "2024-07-02", "reason": "The support arm may unintentionally lower resulting in injury to persons when they are under the\ndisplay ceiling/wall suspension when positioning the displays", "applies": "this device", "via": "K221281" }, { "number": "Z-1167-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-12-21", "reason": "Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values", "applies": "this device", "via": "K173639" }, { "number": "Z-1168-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-12-21", "reason": "Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values", "applies": "this device", "via": "K173639" }, { "number": "Z-1165-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-12-21", "reason": "Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values", "applies": "this device", "via": "K173639" }, { "number": "Z-1002-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-12-09", "reason": "There is potential for the footrest to detach from the patient table during use.\n\nDevice intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.", "applies": "this device", "via": "K173639" }, { "number": "Z-1479-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-11-23", "reason": "Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.", "applies": "this device", "via": "K173639" }, { "number": "Z-1480-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-11-23", "reason": "Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.", "applies": "this device", "via": "K173639" }, { "number": "Z-1481-2023", "classification": "Class II", "status": "ongoing", "initiated": "2022-11-23", "reason": "Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.", "applies": "this device", "via": "K173639" }, { "number": "Z-1685-2021", "classification": "Class II", "status": "terminated", "initiated": "2021-04-20", "reason": "Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not\nhit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube\nbeing misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. \nAND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.", "applies": "this device", "via": "K152928" }, { "number": "Z-0806-2021", "classification": "Class II", "status": "terminated", "initiated": "2020-09-09", "reason": "After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.", "applies": "this device", "via": "K173639" }, { "number": "Z-1338-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.", "applies": "this device", "via": "K173639" }, { "number": "Z-1333-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in\ncollision control creating risk of collision with obstacles or persons when the operator uses the override function.", "applies": "this device", "via": "K173639" }, { "number": "Z-1331-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in\ncollision control creating risk of collision with obstacles or persons when the operator uses the override function.", "applies": "this device", "via": "K173639" }, { "number": "Z-2756-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis", "applies": "this device", "via": "K173639" }, { "number": "Z-2755-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis", "applies": "this device", "via": "K173639" }, { "number": "Z-2757-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis", "applies": "this device", "via": "K173639" }, { "number": "Z-1332-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in\ncollision control creating risk of collision with obstacles or persons when the operator uses the override function.", "applies": "this device", "via": "K173639" }, { "number": "Z-1337-2020", "classification": "Class II", "status": "terminated", "initiated": "2020-01-08", "reason": "A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.", "applies": "this device", "via": "K173639" }, { "number": "Z-0985-2019", "classification": "Class II", "status": "terminated", "initiated": "2019-02-08", "reason": "The swivel arm holding the monitors may become dislodged from the carrying arm.", "applies": "this device", "via": "K173639" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Multitom Rax", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Stationary general-purpose fluoroscopic x-ray system, digital", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "MDR_16_II b_ERLN H 127_RF_combi", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "10860700", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "MDR_16_II b_ERLN H 127_RF_combi", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "04056869009179", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "0405686901995WU", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K152928", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K173639", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K212212", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "K221281", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "OWB", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "JAK", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "JAA", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z11039009", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", 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"values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains endocrine-disrupting substances", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }