Elekta Limited

FDA recalling firm · 5 enforcement events · 6 product records · 2017–2020 · N/A

Elekta Limited has 5 FDA enforcement events on this register (6 product records) between 2017 and 2020: 5 device; the busiest year was 2019 with 3.

0% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
21 May 2020	Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571	Device	Class II	1	Terminated
3 Apr 2019	Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.…	Device	Class II	1	Terminated
12 Mar 2019	Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with…	Device	Class II	1	Terminated
4 Jan 2019	Elekta Unity	Device	Class II	1	Completed
20 Nov 2017	Agility with Integrity R3.2	Device	Class II	2	Terminated

By type and class

Device5

Class II5

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Elekta Limited by year initiated.

Questions and answers

How many FDA recalls has Elekta Limited had?

5 enforcement events (6 product records) on this register, 2017–2020: 5 device.

Are any Elekta Limited recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Elekta Limited recalls?

5 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.