CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report

Leksell GammaPlan Radionuclide RT Treatment planning system recalled

Elekta is recalling Leksell GammaPlan Radionuclide RT Treatment planning system, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1340-2026
FDA event ID: 98212
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2025
FDA classified: 10 Feb 2026
Reported: 18 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

12 Dec 2025	Recall initiated by company
10 Feb 2026	Classified by FDA	+60 days
18 Feb 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

Where it was distributed

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

Nationwide Alaska Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Jersey New Mexico New York Ohio Oklahoma

Questions about this recall

Is Leksell GammaPlan Radionuclide RT Treatment planning system recalled?

Yes. Elekta recalled Leksell GammaPlan Radionuclide RT Treatment planning system on 12 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1340-2026.

Why was it recalled?

Which lots are affected?

Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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