Artis Pheno
Catalogue number 10849000, 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) | K163286 |
| Record published | 2017-05-15 |
| Record revised | 2026-05-06 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 75 % RH; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10849000 | 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
32 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 | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 85 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 119 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 30 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-12 | Class II | Radiation Control for Health and Safety Act | During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient | 73 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-10 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with | U.S. 758, OUS 2077 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-09 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-09 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-08-12 | Class II | Software design | Limited system movements after startup. | 20 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2023-06-19 | Class II | Process control | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator c | 10 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2023-02-02 | Class II | Software design | In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment. | 141 units US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2023-02-02 | Class II | Software design | If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If “Adjust C-arm to Ref” is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the | 141 units US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-16 | Class II | Device Design | Mechanical connection between the tabletop and table base may be lost. | 550 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-09-20 | Class II | Software design | Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be c | 140 US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-08-10 | Class II | Device Design | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to rele | 1,389 (590 US; 799 OUS) (Total) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-06-10 | Class II | Process control | A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically af | 136 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-25 | Class II | Software Design Change | Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and man | 20 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-25 | Class II | Software design | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if | 127 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-12 | Class II | Software design | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during inter | 12 units | 2024-04-11 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-05-27 | Class II | Software design | Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9″) result in canceling clin | 116 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-03-19 | Class II | Software design | Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system. | 133 systems | 2021-11-09 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-04-22 | Class II | Software design | If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only b | 105 systems | 2020-10-09 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-01-24 | Class II | Device Design | Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements | 96 US | 2020-07-10 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-12-20 | Class II | Device Design | The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred. | 6 | 2020-05-01 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-06-06 | Class II | Device Design | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose | 8 | 2021-02-09 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-07-29 | Class II | Device Design | Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. a | 429 total | 2019-05-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-06-22 | Class II | Nonconforming Material/Component | Potential hardware issue which may cause thermal effects and possible damage to system parts. | 605 units in total | 2020-01-15 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-30 | Class II | Device Design | During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stop | 40 in the United States | 2020-02-14 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system’s safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circums | 39 | 2020-03-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.