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…
Read the official notice →- Date
- 2026-02-18
- Country
- United States
- Brand
- Elekta
- Product
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-17
USElekta, 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 → - 2026-03-25
- US
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.
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…
- 2025-11-12
- US
Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The…
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID,…Official notice →
Other drugs & medical recalls in the United States
- 2026-02-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X,…
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC…
Due a design issue where the navigated array connection geometry is incorrect.
FDA · DeviceAlphatec Spine, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO,…Official notice → - US
Laerdal Medical Corporation recalls Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA;…
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
FDA · DeviceLaerdal Medical CorporationWorldwide distribution - US Nationwide and the countries of Denmark, Sweden,…Official notice → - US
AVID Medical, Inc. recalls Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of New Jersey.Official notice → - US
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- US
Medline Industries, LP recalls Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit…
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.