| Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afte recall (Z-2710-2026) | Elekta, Inc. | 2026-07-09 |
| Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Produ recall (Z-2711-2026) | Elekta, Inc. | 2026-07-09 |
| Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device recall (Z-2712-2026) | Elekta, Inc. | 2026-07-09 |
| MOSAIQ Oncology Information System recall (Z-2406-2026) | Elekta, Inc. | 2026-06-11 |
| Brand Name: Leksell Vantage Arc System REF: 1053958 recall (Z-2006-2026) | Elekta, Inc. | 2026-04-29 |
| Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell recall (Z-1581-2026) | Elekta, Inc. | 2026-03-19 |
| Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Soft recall (Z-1339-2026) | Elekta, Inc. | 2026-02-10 |
| Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Soft recall (Z-1340-2026) | Elekta, Inc. | 2026-02-10 |
| Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony recall (Z-1164-2026) | Elekta, Inc. | 2026-01-23 |
| MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000I recall (Z-1078-2026) | Elekta, Inc. | 2026-01-13 |
| Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System recall (Z-0433-2026) | Elekta, Inc. | 2025-11-05 |
| MOSAIQ Oncology Information System recall (Z-1162-2025) | Elekta, Inc. | 2025-02-12 |
| ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Partic recall (Z-0442-2024) | Elekta, Inc. | 2023-12-01 |
| ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation recall (Z-0443-2024) | Elekta, Inc. | 2023-12-01 |
| ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle R recall (Z-0444-2024) | Elekta, Inc. | 2023-12-01 |
| ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy Sy recall (Z-0445-2024) | Elekta, Inc. | 2023-12-01 |
| ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charge recall (Z-0446-2024) | Elekta, Inc. | 2023-12-01 |
| ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System recall (Z-0447-2024) | Elekta, Inc. | 2023-12-01 |
| Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. recall (Z-1675-2023) | Elekta, Inc. | 2023-06-02 |
| Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infini recall (Z-1665-2023) | Elekta, Inc. | 2023-05-30 |
| Monaco RTP System. Used to make treatment plans for patients with prescriptions for extern recall (Z-1233-2023) | Elekta Inc | 2023-03-08 |
| Oncentra Brachy radiation therapy planning system software. recall (Z-0719-2023) | Elekta, Inc. | 2022-12-15 |
| Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: i recall (Z-2289-2020) | Elekta, Inc. | 2020-06-05 |
| Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053 recall (Z-1826-2020) | Elekta Inc | 2020-04-29 |
| Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance recall (Z-1980-2019) | Elekta, Inc. | 2019-07-16 |
| Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of recall (Z-2697-2017) | Elekta, Inc. | 2017-05-31 |
| HexaPOD evo RT System Product Usage: The intended use of the device is the control of accu recall (Z-2691-2016) | Elekta, Inc. | 2016-08-30 |
| iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radio recall (Z-1705-2016) | Elekta, Inc. | 2016-05-23 |
| Monaco - Radiation Treatment Planning used to make treatment plans for patients with presc recall (Z-0181-2016) | Elekta, Inc. | 2015-10-30 |
| Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with recall (Z-0112-2016) | Elekta, Inc. | 2015-10-07 |
| MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage recall (Z-2063-2015) | Elekta, Inc. | 2015-07-14 |
| Laksell GammaPlan, a computer based dose planning system specifically designed for use wit recall (Z-1719-2015) | Elekta, Inc. | 2015-06-05 |
| Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation recall (Z-1712-2015) | Elekta, Inc. | 2015-06-04 |
| Elekta Precise Treatment Table recall (Z-1238-2015) | Elekta, Inc. | 2015-03-19 |
| Focal Sim radiation therapy treatment planning system recall (Z-1244-2015) | Elekta, Inc. | 2015-03-04 |
| Monaco radiation therapy treatment planning system. The Monaco system is used to make trea recall (Z-1237-2015) | Elekta, Inc. | 2015-03-02 |
| Precise Digital Accelerator Intended to be used for radiation therapy treatments of malign recall (Z-1088-2015) | Elekta, Inc. | 2015-02-10 |
| MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows fo recall (Z-0221-2015) | Elekta, Inc. | 2014-11-15 |
| Laksell Gamma Knife Perfexion recall (Z-0152-2015) | Elekta, Inc. | 2014-10-30 |
| Monaco The Monaco system is used to make treatment plans for patients with prescriptions f recall (Z-2581-2014) | Elekta, Inc. | 2014-09-04 |
| FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring an recall (Z-2574-2014) | Elekta, Inc. | 2014-09-03 |
| MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment pla recall (Z-1869-2014) | Elekta, Inc. | 2014-06-25 |
| iGUIDE System Product Usage: The intended use of the device is the control of accurate pat recall (Z-1807-2014) | Elekta, Inc. | 2014-06-17 |
| Synergy XVI Intended for radiation therapy treatment. recall (Z-1724-2014) | Elekta, Inc. | 2014-06-16 |
| MOSAIQ, an oncology information system used to manage workflows for treatment planning and recall (Z-1800-2014) | Elekta, Inc. | 2014-06-16 |
| HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation ther recall (Z-1514-2014) | Elekta, Inc. | 2014-04-25 |
| Integrity 1.1. Integrity is the interface and control software for the Elekta range of med recall (Z-1322-2014) | Elekta, Inc. | 2014-04-02 |
| SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments recall (Z-1064-2014) | Elekta, Inc. | 2014-03-14 |
| XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient recall (Z-1197-2014) | Elekta, Inc. | 2014-03-13 |
| All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or recall (Z-1065-2014) | Elekta, Inc. | 2014-03-07 |
| RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is inte recall (Z-1081-2014) | Elekta, Inc. | 2014-03-06 |
| Desktop Pro TM linear accelerator control software intended to assist a licensed practitio recall (Z-1082-2014) | Elekta, Inc. | 2014-03-06 |
| Integrity. Version 1.1 of the Integrity interface and control software for the Elekta rang recall (Z-1083-2014) | Elekta, Inc. | 2014-03-06 |
| Agility. Version 3.0 of the Integrity interface and control software for the Elekta range recall (Z-1084-2014) | Elekta, Inc. | 2014-03-06 |
| Agility. Version 3.1 of the Integrity interface and control software for the Elekta range recall (Z-1085-2014) | Elekta, Inc. | 2014-03-06 |
| DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to c recall (Z-0978-2014) | Elekta, Inc. | 2014-02-25 |
| Synergy XVI XVI can incorrectly calculate the target position of the treatment table, beca recall (Z-1059-2014) | Elekta, Inc. | 2014-02-20 |
| Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of recall (Z-1061-2014) | Elekta, Inc. | 2014-02-20 |
| XiO RTP System. Used to create treatment plans for any cancer patient for whom external be recall (Z-0928-2014) | Elekta, Inc. | 2014-02-04 |
| XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient recall (Z-0780-2014) | Elekta, Inc. | 2014-01-17 |
| Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is recall (Z-0138-2014) | Elekta, Inc. | 2013-11-04 |
| Monaco RTP System Radiation treatment planning recall (Z-2276-2013) | Elekta, Inc. | 2013-09-25 |
| Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment plannin recall (Z-2277-2013) | Elekta, Inc. | 2013-09-25 |
| DMLC IV-ERGO - Beam shaping block for Radiation Therapy. recall (Z-2157-2013) | Elekta, Inc. | 2013-09-04 |
| Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when ad recall (Z-1402-2013) | Elekta, Inc. | 2013-05-25 |
| Precise Treatment Table. To be used as part of radiation therapy treatment process. recall (Z-1072-2013) | Elekta, Inc. | 2013-04-09 |
| Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5 recall (Z-0931-2013) | Elekta, Inc. | 2013-03-10 |
| Elekta, Apex add-on Micro MLC, collimator for radiation therapy. recall (Z-0885-2013) | Elekta, Inc. | 2013-02-26 |
| Monaco RTP System. Radiation treatment planning. recall (Z-0841-2013) | Elekta, Inc. | 2013-02-20 |
| MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology recall (Z-0169-2013) | Elekta, Inc. | 2012-10-30 |
| Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and recall (Z-0118-2013) | Elekta, Inc. | 2012-10-23 |
| Precise Digital Accelerator Delivery of radiation to defined target volumes recall (Z-2405-2012) | Elekta, Inc. | 2012-09-19 |
| Multileaf Collimator To be used for single or multiple fractions, delivered as static and/ recall (Z-2340-2012) | Elekta, Inc. | 2012-09-10 |
| Focal SIM Planning of radiation therapy recall (Z-2002-2012) | Elekta, Inc. | 2012-07-12 |
| Monaco Product Usage: Planning of radiation therapy recall (Z-2007-2012) | Elekta, Inc. | 2012-07-12 |
| MLCi/MCLi2. Radiation therapy. recall (Z-1651-2012) | Elekta, Inc. | 2012-05-23 |
| Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process. recall (Z-1066-2012) | Elekta, Inc. | 2012-02-21 |
| Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy t recall (Z-0320-2012) | Elekta, Inc. | 2011-12-01 |
| Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy tre recall (Z-0342-2012) | Elekta, Inc. | 2011-12-01 |
| Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed fo recall (Z-0307-2012) | Elekta, Inc. | 2011-11-30 |
| Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a telethe recall (Z-0312-2012) | Elekta, Inc. | 2011-11-30 |
| Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient' recall (Z-0319-2012) | Elekta, Inc. | 2011-11-30 |
| Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic recall (Z-0305-2012) | Elekta, Inc. | 2011-11-29 |
| Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy trea recall (Z-3079-2011) | Elekta, Inc. | 2011-08-29 |
| Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as d recall (Z-1723-2011) | Elekta, Inc. | 2011-03-22 |
| Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelera recall (Z-1555-2011) | Elekta, Inc. | 2011-03-04 |
| PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therap recall (Z-1556-2011) | Elekta, Inc. | 2011-03-04 |
| PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments. recall (Z-1476-2011) | Elekta, Inc. | 2011-03-02 |
| Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial recall (Z-1251-2011) | Elekta, Inc. | 2011-02-15 |
| Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic disea recall (Z-1252-2011) | Elekta, Inc. | 2011-02-15 |
| Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatment recall (Z-1223-2011) | Elekta, Inc. | 2011-02-14 |
| Precise Treatment Table The Precise Treatment Table is intended as a universal patient tre recall (Z-1030-2011) | Elekta, Inc. | 2011-02-03 |
| Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the recall (Z-0538-2011) | Elekta, Inc. | 2010-12-03 |
| Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument recall (Z-0163-2011) | Elekta, Inc. | 2010-10-28 |
| Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell recall (Z-1604-2010) | Elekta, Inc. | 2010-05-14 |
| Leksell Gamma Knife C recall (Z-1533-2010) | Elekta, Inc. | 2010-04-29 |
| Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manu recall (Z-1134-2010) | Elekta, Inc. | 2010-04-27 |
| Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic recall (Z-1441-2010) | Elekta, Inc. | 2010-04-27 |
| iView GT Electronic Portal Imaging Device, used with radiation therapy treatments. recall (Z-1436-2010) | Elekta, Inc. | 2010-04-26 |
| Precise Treatment Table Intended as a universal patient treatment support and positioning recall (Z-1432-2010) | Elekta, Inc. | 2010-04-23 |