Every recall we track for Elekta, Inc. — 49 in all — plus the complaints and injury reports the public filed about them.
Elekta recalls MOSAIQ Oncology Information System software version 3.2 due to potential failure to load adapted baseline shift plans during treatment, risking incorrect radiation therapy delivery.
Elekta recalls Geneva Brachytherapy Applicators with specific lot codes due to potential IU tube detachment after treatment, which could remain in patients. Affected units include certain lot numbers for cervical cancer therapy devices.
Elekta recalls Advanced Gynecological Applicators due to potential IU tube detachment during cancer treatment. Affected units have specific lot codes; contact for remedy.
Elek: Recall of Fletcher CT/MR Shielded Applicator Set due to potential IU tube detachment after use. Affected units may cause retained tissue in patients.
Elekta recalls Leksell Vantage Arc System devices with potential shifting coordinates during procedures. Affected units have specific serial numbers and lot codes. Contact Elekta for remedy details.
Elekta recalls Leksell Gamma Knife Perfexion and Icon models with adapter not properly aligned or locked, posing a risk of improper function during radiosurgery procedures.
Elekta recalls Synergy, Harmony, Infinity, and Versa HD linear accelerators due to electrical grounding issues. Affected units may have safety risks during medical treatments.
Elekta recalls Leksell GammaPlan 11.1 software due to potential risk of irradiating the wrong patient location during radiation treatment planning. Affected units may require software updates to prevent errors.
Elekta recalls Leksell GammaPlan radionuclide RT treatment planning software versions 11.3 and 11.4 due to potential risk of irradiating the wrong patient location during treatment planning.
Elekta recalls specific versions of MOSAIQ Oncology Information System with Particle Therapy License due to potential for repeated partial treatments causing overtreatment. Affected software versions include 3.10.200 to 3.2.3.1.
Elekta recalls Leksell Vantage Stereotactic System due to risk of paint flakes separating and entering surgical wounds during neurosurgery. Affected units have specific serial numbers.
Elekta recalls specific versions of its MOSAIQ Oncology Information System software due to potential incorrect image offsets for Linear Accelerators not characterized at IEC61217 scale.
Elekta recalls specific medical radiation therapy systems (MRT 6001/6011) due to potential uncontrolled detector arm extension if microswitch is incorrectly set up. Affected units have serial numbers listed in the recall.
Elekta recalls specific models of Synergy radiation therapy systems with potential for uncontrolled detector arm extension if microswitch is incorrectly set up. Affected units have serial numbers listed in the recall notice.
Elekta recalls specific AXESSE radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected models include XRT 2181 and XRT 27891 with listed serial numbers.
Elekta recalls specific Versa HD models with potential uncontrolled detector arm extension if microswitch is incorrectly set up. Affected units have serial numbers listed in the recall notice.
Elekta recalls specific models of medical radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include those with serial numbers listed in the recall notice.
Elekta recalls specific models of Infinity radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include serial numbers starting with 152596 to 154565.
Elekta recalls specific models of medical linear accelerators due to a component non-compliant with IEC 60601 standards. Affected units include Elekta Infinity, Versa HD, and Elekta Synergy with specific serial numbers.
Elekta recalls Unity Image-Guided Radiation Therapy Systems with a potential overheating electrical connector in the MR gradient coil. This low-risk issue may require monitoring but does not mandate immediate action.
Elekta recalls Monaco RTP System software versions 5.11.00-5.11.03 due to potential inaccurate radiation dose calculations in treatment plans. Affected users should contact Elekta for details.
Elekta recalls Oncentra Brachy radiation therapy software versions 4.0+ with reconstruction errors in Catheter Bending features. Affected units have specific UDI GTIN numbers listed. No remedy provided in official notice.
Elekta recalls Oncentra Brachy software versions 4.0 and above with specific Applicator Modeling license (170283-00) due to potential dose delivery differences between planned and actual radiation treatment.
Elekta recalls specific medical linear accelerators due to risk of diode failure when removed, potentially causing injury. Affected models include Precise Digital, Harmony, Synergy, Infinity, and Versa HD systems.
Elekta recalls Monaco radiation treatment software versions 5.40.00-5.40.02 and 5.51.10 due to potential unintended contour changes saving image sets, which could affect radiation treatment plans.
Elekta recalls MOSAIQ Oncology Information System software version 2.83 where drug strength settings may revert to original after ordering changes. Affected units run with First Data Bank (FDB) and have specific UDI/GTIN numbers.
Elekta recalls Monaco RTP System software builds 5.40.00-5.51.10 due to potential dose calculation errors if couch is removed and added during plan loading. Affected users should contact Elekta for details.
Elekta recalls specific versions of its MOSAIC Oncology Information System (2.62, 2.64, 2.70, 2.81, 2.82, 2.83) hosted on Classic Cloud due to malware vulnerability. Affected users should check their version numbers and contact support.
Elekta recalls Unity radiation therapy systems with serial numbers 600001-600043 due to potential Legionella in heat exchanger condensation tray. Affected units may need cleaning or inspection.
Elekta recalls Monaco RTP radiation treatment software version 5.40.00 and 5.40.01 due to potential inaccurate radiation dose delivery. Affected users should contact Elekta for details.
Elekta recalls Leksell Vantage Stereotactic System Instrument Carrier (serial numbers SH00106 to SH00178) due to a faulty locking piece that may not secure properly to the Arc system.
Elekta recalls specific Unity radiation therapy systems due to reported excessive heating in the MRL Gradient Connection Module. Affected units have serial numbers starting with 600014 to 600035. Contact Elekta for details.
Elekta recalls Monaco radiation treatment planning software builds 5.40.00, 5.50.00, and 5.51.00 due to incorrect energy optimization during dose calculations. Affected users should contact Elekta for remediation.
a ~150-character meta description summarising the recall.
Elekta recalls Monaco RTP System software versions 5.50 and 5.51 due to potential incorrect radiation dose calculations, which could affect cancer treatment safety. Affected users should contact Elekta for details.
a ~150-character meta description summarising the recall.
Elekta recalls Monaco RTP software versions 5.10 and 5.11 due to potential incorrect monitor unit scaling during radiation treatment planning. Affected units may require software update to prevent treatment errors.
Elekta recalls Unity radiation therapy systems due to QA software not displaying MR to MV offset values, risking treatment errors. Affected units include specific model numbers and installation dates.
Elekta recalls iGUIDE System software versions 2.2.0-2.2.2 due to potential incorrect 3D position monitoring. Affected units have specific GTIN numbers and were sold with these software builds.
Elek: Monaco radiation treatment software version 5.40 may use incorrect dose optimization models during plan adaptation. Affected users should contact Elekta for details.
Elekta recalls MOSAIQ Oncology Information System and Sequencer versions 1.0+ and 6.1+ due to potential overdose from missing wedge IDs in radiation treatment plans.
Elekta recalls MOSAIQ Oncology Information System Version 2.64 due to potential incorrect isocenter settings when copying treatment fields, which could affect radiation therapy accuracy.
Elekta recalls MOSAIQ Oncology Information System software builds 2.64 SP3 and higher due to order status not updating correctly after completion. Affected users should contact support for updates.
Elekta recalls HexaPOD evo RT Couch Top (HexaPOD evo Module) due to potential incorrect patient positioning after 6D radiation therapy workflows. Affected units have specific serial numbers.
a ~150-character meta description summarising the recall.
