Elekta recalls

Elekta has 122 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 15 Jul 2026. 33 are still ongoing. 11 were reported in the last 12 months.

Total recalls122since 2012

Last 12 months11reported

Class I00% of total

Ongoing33latest 15 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 1Feb 0 0 0May 0 0 0Aug 0 0 1Nov 0 1 3Feb 1 0 1May 1 3 0Aug 0 0

Severity split

Class I 0 0%Class II 122 100%Class III 0 0%

Why elekta is recalled

Product types

By year

2026108%
202522%
202397%
202211%
202165%
202054%
20191311%
201854%
201787%
20161411%

Ongoing elekta recalls

33 active

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Fletcher CT/MR Shielded Applicator Set Intracavitary Remote recalled	Elekta	Other	Nationwide
17 Jun 2026Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Leksell Vantage Arc System recalled by Elekta	Elekta	Device Malfunction	28 states
25 Mar 2026Device	CLASS II	Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" recalled	Elekta	Other	Nationwide

All elekta recalls, newest first

122 total

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Fletcher CT/MR Shielded Applicator Set Intracavitary Remote recalled	Elekta	Other	Nationwide
17 Jun 2026Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Leksell Vantage Arc System recalled by Elekta	Elekta	Device Malfunction	28 states
25 Mar 2026Device	CLASS II	Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" recalled	Elekta	Other	Nationwide
18 Feb 2026Device	CLASS II	Leksell GammaPlan Radionuclide RT Treatment planning system recalled	Elekta	Device Malfunction	Nationwide
18 Feb 2026Device	CLASS II	Leksell GammaPlan Radionuclide RT Treatment planning system recalled	Elekta	Device Malfunction	Nationwide
4 Feb 2026Device	CLASS II	Medical Linear Accelerator Elekta Synergy, Elekta Harmony recalled	Elekta	Device Malfunction	GA
21 Jan 2026Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Other	Nationwide
12 Nov 2025Device	CLASS II	Leksell Stereotactic System Leksell Vantage Stereotactic System recalled	Elekta	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Device Malfunction	5 states
13 Dec 2023Device	CLASS II	Precise Digital Accelerator recalled by Elekta	Elekta	Other	GA
13 Dec 2023Device	CLASS II	Elekta Synergy recalled	Elekta	Other	GA
13 Dec 2023Device	CLASS II	Elekta Axesse, REF XRT 2181, XRT 27891; Medical Charged-Particle recalled	Elekta	Other	GA
13 Dec 2023Device	CLASS II	Versa HD recalled by Elekta	Elekta	Other	GA
13 Dec 2023Device	CLASS II	Elekta Synergy Platform recalled	Elekta	Other	GA
13 Dec 2023Device	CLASS II	Elekta Infinity recalled	Elekta	Other	GA
14 Jun 2023Device	CLASS II	Unity Image-Guided Radiation Therapy System recalled by Elekta	Elekta	Other	Nationwide
7 Jun 2023Device	CLASS II	Medical Linear Accelerator (ELMA) included in the below platforms recalled	Elekta	Other	7 states
15 Mar 2023Device	CLASS II	Monaco RTP System recalled by Elekta	Elekta	Labeling Errors	Nationwide
21 Dec 2022Device	CLASS II	Oncentra Brachy radiation therapy planning system recalled by Elekta	Elekta	Device Malfunction	Nationwide
3 Nov 2021Device	CLASS II	Oncentra Brachy users using recalled by Elekta	Elekta	Other	GA
20 Oct 2021Device	CLASS II	Medical Linear Accelerator (EMLA), configured as follows recalled	Elekta	Device Malfunction	Nationwide
6 Oct 2021Device	CLASS II	Elekta Monaco - Product Usage: used to make treatment plans recalled	Elekta	Other	Nationwide
6 Oct 2021Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Other	17 states
8 Sep 2021Device	CLASS II	Monaco RTP System recalled by Elekta	Elekta	Device Malfunction	7 states
9 Jun 2021Device	CLASS II	Mosaic Oncology Information System versions recalled by Elekta	Elekta	Other	Nationwide
8 Jul 2020Device	CLASS II	Unity, Image-Guided Radiation Therapy System recalled by Elekta	Elekta	Other	IA, NY, PA
17 Jun 2020Device	CLASS II	Unity, Philips Marlin recalled by Elekta	Elekta	Device Malfunction	5 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.