Elekta Unity
Indexing Bars
8manufacturers in China registered for this device type
6catalogue numbers in this listing
19510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Elekta Inc., United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K182076 |
| Record published | 2021-11-30 |
| Record revised | 2022-11-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1553106 | In distribution | |
| 1075900 | In distribution | |
| 1065120 | In distribution | |
| 1059073 | In distribution | |
| 1536549 | In distribution | |
| 1082525 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| AlignRT Plus | Vision RT Limited | 72 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210500 | 2021-06-11 |
| K192482 | 2019-12-05 |
| K192242 | 2019-11-22 |
| K182076 | 2018-12-04 |
| K183034 | 2018-12-04 |
| K153011 | 2015-12-11 |
| K141855 | 2014-10-08 |
| K131965 | 2013-09-25 |
| K123808 | 2013-04-04 |
| K121663 | 2012-12-05 |
| K121328 | 2012-06-12 |
| K111332 | 2012-01-30 |
| K112613 | 2011-12-16 |
| K102200 | 2010-11-04 |
| K100115 | 2010-03-10 |
| K082122 | 2008-08-29 |
| K080585 | 2008-06-11 |
| K051932 | 2005-08-12 |
| K042794 | 2005-01-31 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Elekta Inc. | UDI-DI | 2023-04-06 | Class II | Process design | There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. | 18 devices | |
| Elekta Inc. | UDI-DI | 2020-05-21 | Class II | Device Design | In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. | 26 units | 2024-08-19 |
| Elekta Inc. | 510(k) number | 2019-06-24 | Class II | Software design | The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA. | 12 units | 2021-04-01 |
| Elekta Inc. | 510(k) number | 2019-04-03 | Class II | Labeling design | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. | 9 devices | 2023-05-01 |
| Elekta Inc. | 510(k) number | 2019-03-12 | Class II | Software design | Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are | 12 units | 2023-11-03 |
| Elekta Inc. | 510(k) number | 2019-01-04 | Class II | Under Investigation by firm | In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore. | 2 units |
Recalls
34 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 |
|---|---|---|---|---|---|
| 2026-05-21 | Class II | Software design | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. | 12 programs | |
| 2025-12-14 | Class II | Process control | Due to a manufacturing issue and electrical grounding of systems. | 5391 | |
| 2025-12-10 | Class II | Software change control | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followe | 1 | |
| 2025-01-15 | Class II | Software design | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. | 64 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 291 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 264 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 1019 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 47 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 451 units | |
| 2023-10-25 | Class II | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncont | 315 units | |
| 2023-05-05 | Class II | Under Investigation by firm | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 | 46 units | |
| 2021-09-17 | Class II | Under Investigation by firm | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. | 4,405 units | 2024-09-30 |
| 2021-09-02 | Class II | Software design | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. | 31 | |
| 2021-04-20 | Class II | Under Investigation by firm | Malware attack | 40 units | 2023-01-17 |
| 2020-04-30 | Class II | Under Investigation by firm | potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. | 32 units | 2021-08-04 |
| 2019-12-18 | Class II | Process control | There have been reports of excessive heating in the MRL Gradient Connection Module. | 21 devices | 2021-06-15 |
| 2019-06-19 | Class II | Software Design Change | Potential for iGUIDE to incorrectly monitor the 3D position. | 374 devices | 2024-05-06 |
| 2018-12-13 | Class II | Software change control | There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the | 3,950 units total (1,747 US) | |
| 2018-12-04 | Class II | Software design | If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it i | 551 units | 2026-02-23 |
| 2018-08-03 | Class II | Unknown/Undetermined by firm | Order Status Remains Approved When Should Indicate Complete. | 185 | 2024-09-23 |
| 2017-12-01 | Class II | Component design/selection | There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. | 2,998 | 2019-11-05 |
| 2017-11-20 | Class II | Software Design Change | Potential for positional errors following automatic table movement (ATM). | 539 units total | 2024-03-15 |
| 2017-11-20 | Class II | Software Design Change | Potential for positional errors following automatic table movement (ATM). | 539 units total | 2024-03-15 |
| 2017-06-21 | Class II | Software design | Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans. | 355 units | 2018-07-11 |
| 2017-06-19 | Class II | Unknown/Undetermined by firm | Incorrect PEC values. | 110 units | 2019-11-05 |
| 2016-12-02 | Class II | Software design | Edits to Particle field definition parameters may not be saved when the field definition window is saved. | 47 | 2021-11-05 |
| 2016-08-18 | Class II | Nonconforming Material/Component | Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position. | 13 | 2017-05-23 |
| 2016-07-15 | Class II | Software Design Change | It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. | 383 | |
| 2016-07-08 | Class II | Other | There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. | 553 | 2017-11-24 |
| 2016-06-17 | Class II | Software design | It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan. | 69 | 2020-08-18 |
| 2016-05-12 | Class II | Software design | If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial s | 20 | 2021-07-16 |
| 2015-12-09 | Class II | Software design | Incorrect drug dosage due to “Age Limit” and patient weight data item issue. | 399 | 2022-09-27 |
| 2015-11-24 | Class II | Software design | First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-all | 211 | 2021-09-15 |
| 2015-07-01 | Class II | Software design | A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones. | 74 Total (45 US) | 2021-09-15 |
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.