Luminos Lotus Max
Catalogue number 11574100, listed by Siemens Healthcare Limited, Canada, under Interventional Fluoroscopic X-Ray System. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K173639 |
| Record published | 2020-11-01 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11574100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
Recalls Naming This Product
17 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-12-05 | Class II | Radiation Control for Health and Safety Act | A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand.When switching quickly between organ programs (OGPs) the collim | U.S.: 1, OUS: 95 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2024-07-02 | Class II | Under Investigation by firm | The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays | 333 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2024-07-02 | Class II | Under Investigation by firm | The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays | 24 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2024-07-02 | Class II | Under Investigation by firm | The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays | 26 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-21 | Class II | Software design | 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 | 28 units. Expanded Recall: 506 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-21 | Class II | Software design | 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 | 2 units; Expanded recall: 53 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-21 | Class II | Software design | 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 | 7 units; Exanded recall: 215 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-09 | Class II | Process control | There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastro | 886 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-11-23 | Class II | Radiation Control for Health and Safety Act | 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- | 704 units in the United States (1945 units worldwide) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-11-23 | Class II | Radiation Control for Health and Safety Act | 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- | 704 units in the United States (1945 units worldwide) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-11-23 | Class II | Radiation Control for Health and Safety Act | 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- | 704 units in the United States (1945 units worldwide) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-08 | Class II | Use error | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function. | 46 | 2022-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-08 | Class II | Use error | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function. | 475 | 2022-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-08 | Class II | Use error | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function. | 192 | 2022-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-08 | Class II | Software design | A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. | 46 | 2022-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-08 | Class II | Software design | A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. | 475 | 2022-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-02-08 | Class II | Device Design | The swivel arm holding the monitors may become dislodged from the carrying arm. | 191 | 2020-05-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
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