Device recall: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell…

Class II FDA enforcement event 98443. Recall start date: 18 Feb 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Due to adapter not being properly aligned or locked in place.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Elekta, Inc. started this device recall on 18 Feb 2026. The firm address in the FDA record is in Atlanta, GA. FDA put the recall in Class II. FDA event 98443 has 1 product record. The first FDA enforcement report date is 25 Mar 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX,…

Recalling firm

Elekta, Inc., Atlanta, GA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 98443: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1581-2026	Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell Gamma Knife Elekta Esprit Leksell Gamma Knife (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is…	352	Class II	Ongoing	25 Mar 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 105

Other events of the firm

Other FDA enforcement events of Elekta, Inc.
Initiated	Product (first record)	Type	Class	Records
21 May 2026	MOSAIQ Oncology Information System	Device	Class II	1
3 Apr 2026	Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product De	Device	Class II	3
19 Mar 2026	Brand Name: Leksell Vantage Arc System REF: 1053958	Device	Class II	1
14 Dec 2025	Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD So	Device	Class II	1
12 Dec 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Des	Device	Class II	2
10 Dec 2025	MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)	Device	Class II	1
30 Sep 2025	Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product	Device	Class II	1
15 Jan 2025	MOSAIQ Oncology Information System	Device	Class II	1
25 Oct 2023	ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac	Device	Class II	6
5 May 2023	Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Syn	Device	Class II	1

Elekta, Inc.: all 105 events

Official channels

FDA enforcement report Z-1581-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98443. https://recallregister.com/fda/ii/98443/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX,…
What quantity of product is in FDA event 98443?: The FDA record gives this quantity: 352
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.