Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
Due to adapter not being properly aligned or locked in place.
Read the official notice →- Date
- 2026-03-25
- Country
- United States
- Brand
- Elekta
- Product
- Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Elekta recalls
- 2026-07-15
USElekta, Inc. recalls Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AR, AZ,…Official notice →- 2026-06-17
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Elekta, Inc. recalls MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA · DeviceElekta, Inc.Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY,…Official notice → - 2026-05-06
- US
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
FDA · DeviceElekta, Inc.US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA…Official notice → - 2026-02-18
- US
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description:…
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…
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice → - 2026-02-04
- US
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version:…
Due to a manufacturing issue and electrical grounding of systems.
- 2026-01-21
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial…
Other drugs & medical recalls in the United States
- 2026-03-25
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Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
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Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
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ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
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Cribs sold in the USA are missing two access door warning labels.
FDA · DeviceStryker Medical Division of Stryker CorporationUS Nationwide distribution.Official notice → - US
LeMaitre Vascular, Inc. recalls Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
- US
Baxter Healthcare Corporation recalls Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version:…
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS,…Official notice →