Elekta, Inc.: 58 recalls on record

Recalls filed with 1 agency: FDA (58).

First recall on record: July 18, 2012. Most recent: July 15, 2026.

Risk classification: Class II: 58

Most recent recalls

DateAgencyProduct
July 15, 2026FDABrand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Pr…Z-2711-2026
July 15, 2026FDABrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Af…Z-2710-2026
July 15, 2026FDABrand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The devi…Z-2712-2026
June 17, 2026FDAMOSAIQ Oncology Information SystemZ-2406-2026
May 6, 2026FDABrand Name: Leksell Vantage Arc System REF: 1053958Z-2006-2026
February 18, 2026FDABrand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system S…Z-1340-2026
January 21, 2026FDAMOSAIQ Oncology Information System with Particle Therapy License (License Kit 4570000000…Z-1078-2026
June 17, 2020FDAElekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: …Z-2289-2020
October 2, 2019FDAMonaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The …Z-2561-2019
February 20, 2019FDAMOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information sy…Z-0821-2019
July 19, 2017FDALeksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of…Z-2697-2017
January 18, 2017FDAMonaco RTP System Product Usage: Used to make treatment plans for patients with presc…Z-1009-2017
January 18, 2017FDAOncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy p…Z-0987-2017
December 21, 2016FDAMOSAIQ Oncology Information System The product is used to manage workflows for treatm…Z-0731-2017
September 14, 2016FDAMedical Linear AcceleratorZ-2721-2016
August 3, 2016FDAMOSAIQ Oncology Information SystemZ-2293-2016
July 6, 2016FDAMOSAIQ Oncology Information SystemZ-2052-2016
June 1, 2016FDAiGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radi…Z-1705-2016
January 6, 2016FDAMOSAIQ Oncology Information System MOSAIQ is an oncology information system used to ma…Z-0557-2016
February 18, 2015FDAPrecise Digital Accelerator Intended to be used for radiation therapy treatments of ma…Z-1088-2015
November 26, 2014FDAMOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflo…Z-0221-2015
November 5, 2014FDALaksell Gamma Knife PerfexionZ-0152-2015
September 10, 2014FDAFOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contour…Z-2574-2014
September 10, 2014FDAMonaco The Monaco system is used to make treatment plans for patients with prescripti…Z-2581-2014
July 2, 2014FDAMOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment…Z-1869-2014

Questions about this company

How many recalls does Elekta, Inc. have?
Recalert has 58 U.S. recalls on record for Elekta, Inc., published between July 18, 2012 and July 15, 2026.
What was the most recent Elekta, Inc. recall?
FDA recall Z-2711-2026, published July 15, 2026: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy fo…
Which agencies have handled Elekta, Inc. recalls?
Elekta, Inc. appears as the recalling firm in recalls from: FDA (58).

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