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

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 1 0 1Jan '26 3 1 0Apr 1 1 3Jul 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

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.