Biograph Trinion.X EP5 CT64
Catalogue number 11713854, listed by Siemens Medical Solutions USA, Inc., United States, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
105510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| 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 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K251561 |
| Record published | 2026-01-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11713854 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253574 | 2026-03-20 |
| K251805 | 2025-10-15 |
| K251061 | 2025-07-28 |
| K250822 | 2025-07-03 |
| K243523 | 2025-02-12 |
| K241757 | 2025-01-03 |
| K241295 | 2024-09-03 |
| K233657 | 2024-03-28 |
| K233650 | 2024-03-26 |
| K232136 | 2024-01-04 |
| K232206 | 2023-12-06 |
| K232155 | 2023-11-30 |
| K230421 | 2023-06-16 |
| K222361 | 2022-10-20 |
| K221727 | 2022-07-13 |
| K220814 | 2022-07-12 |
| K221219 | 2022-05-17 |
| K212889 | 2022-03-28 |
| K220450 | 2022-03-07 |
| K214019 | 2022-01-20 |
| K213096 | 2021-12-06 |
| K211591 | 2021-09-30 |
| K211373 | 2021-08-27 |
| K203411 | 2021-07-22 |
| K203699 | 2021-04-30 |
| K202213 | 2020-10-11 |
| K193277 | 2020-07-22 |
| K201034 | 2020-05-14 |
| K200524 | 2020-04-01 |
| K193267 | 2020-03-16 |
| K192763 | 2019-12-17 |
| K192061 | 2019-11-21 |
| K191891 | 2019-11-06 |
| K192402 | 2019-09-20 |
| K183268 | 2019-09-10 |
| K183271 | 2019-07-26 |
| K191468 | 2019-07-03 |
| K190578 | 2019-06-27 |
| K183548 | 2019-04-15 |
| K173632 | 2018-04-13 |
| K173637 | 2018-03-30 |
| K173630 | 2018-03-30 |
| K173607 | 2018-03-21 |
| K173625 | 2018-03-08 |
| K163297 | 2017-03-24 |
| K163296 | 2017-03-21 |
| K163284 | 2017-03-01 |
| K163341 | 2017-02-09 |
| K162302 | 2016-12-16 |
| K161196 | 2016-08-24 |
| K151765 | 2016-03-25 |
| K151749 | 2016-03-18 |
| K153220 | 2016-02-19 |
| K142955 | 2015-11-24 |
| K151752 | 2015-11-12 |
| K150713 | 2015-11-02 |
| K152036 | 2015-10-09 |
| K150757 | 2015-08-11 |
| K150745 | 2015-08-11 |
| K150785 | 2015-05-18 |
| K143416 | 2015-04-16 |
| K143400 | 2015-04-08 |
| K143401 | 2015-04-06 |
| K143409 | 2015-03-26 |
| K142584 | 2015-01-16 |
| K133677 | 2014-10-16 |
| K140912 | 2014-09-15 |
| K140232 | 2014-08-14 |
| K133648 | 2014-07-07 |
| K133590 | 2014-04-30 |
| K133589 | 2014-04-17 |
| K132902 | 2014-04-07 |
| K133424 | 2014-01-17 |
| K123584 | 2013-03-12 |
| K123585 | 2012-12-20 |
| K113287 | 2012-05-23 |
| K103424 | 2011-11-22 |
| K103127 | 2011-03-04 |
| K083524 | 2009-04-01 |
| K082220 | 2008-10-10 |
| K081022 | 2008-06-02 |
| K062351 | 2006-10-05 |
| K043086 | 2004-12-23 |
| K043087 | 2004-12-15 |
| K040665 | 2004-04-02 |
| K032475 | 2003-11-10 |
| K032536 | 2003-11-10 |
| K022013 | 2002-07-16 |
| K011447 | 2001-08-03 |
| K003152 | 2000-10-24 |
| K003014 | 2000-10-12 |
| K991764 | 1999-08-17 |
| K990426 | 1999-05-12 |
| K982349 | 1998-09-30 |
| K971717 | 1997-09-03 |
| K971054 | 1997-06-13 |
| K965004 | 1997-03-11 |
| K964747 | 1997-02-10 |
| K960635 | 1996-04-03 |
| K923524 | 1994-05-17 |
| K924985 | 1994-04-07 |
| K913996 | 1991-11-22 |
| K910859 | 1991-05-17 |
| K875088 | 1988-07-26 |
| K880965 | 1988-03-28 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-12-19 | Class II | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | 2 units | |
| 2025-12-19 | Class II | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | 2 units | |
| 2025-12-19 | Class II | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | 88 units | |
| 2025-12-19 | Class II | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | 5 units | |
| 2022-12-22 | Class II | Under Investigation by firm | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped | 29 units U.S. | |
| 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) | |
| 2022-05-20 | Class II | Process control | During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation. | 195 worldwide, 88 US | |
| 2022-03-07 | Class II | Software change control | Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. | 15 (US) | 2023-12-19 |
| 2022-03-07 | Class II | Software design | Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient | 547 units US | |
| 2022-03-07 | Class II | Software change control | Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. | 1 (US) | 2023-12-19 |
| 2022-03-07 | Class II | Software change control | Upgraded software version makes an automatic change in laser configuration settings for “markerless workflow” which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. | 14 (US) | 2023-12-19 |
| 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 80 units | |
| 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 108 units | |
| 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 794 units | |
| 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | ||
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 121 unit | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 232 units | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 104 units | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 75 units | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 665 units | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 298 units | 2024-01-16 |
| 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 64 units | 2024-01-16 |
| 2021-08-18 | Class II | Software design | Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan a | 31 units US | |
| 2021-08-16 | Class II | Software design | Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS). | 44 systems | |
| 2021-03-03 | Class II | Software design | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. S | 190 units US | 2023-12-28 |
| 2020-11-24 | Class II | Software design | System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan | 3044 | 2024-02-06 |
| 2020-06-22 | Class II | Software design | Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan | 767 distributed in U.S. | 2021-03-09 |
| 2019-10-07 | Class II | Software design | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes | 305 units | 2022-11-14 |
| 2019-09-24 | Class II | Software design | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures | 14 US | 2024-07-08 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 10 units | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 3 units | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 18 units | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 12 units | 2020-12-02 |
| 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| 2019-07-25 | Class II | Software design | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in d | 2867 units worldwide (OUS); 1464 units US | 2022-12-29 |
| 2019-07-03 | Class II | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. | 2024-05-10 | |
| 2019-07-03 | Class II | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. | 2024-05-10 | |
| 2019-07-03 | Class II | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. | 2024-05-10 |
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.