Elekta, Inc.
79 recalls on record · Latest: Feb 18, 2026
Elekta, Inc. Recall Insight
Elekta, Inc. appears on 79 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.094% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 26, 2014 to Feb 18, 2026.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell Ga…
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
MOSAIQ Oncology Information System
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Syn…
MOSAIQ Oncology Information System
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotact…
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients…
Monaco Radiation Treatment Planning System (RTP) System
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients w…
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients …
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments an…
Monaco Radiation Treatment Planning (RTP) System
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and del…
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and de…
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axess…
MOSAIQ Oncology Information System
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a f…
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation trea…
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow amon…
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system …
Medical Linear Accelerator
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracki…
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
MOSAIQ Oncology Information System
MOSAIQ Oncology Information System
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging…
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It suppo…
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachythe…
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It support…
Elekta Precise Treatment Table
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed med…
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports informati…
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Other firms with recall activity tracked in the PlainRecalls index.
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