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
Read the official notice →- Date
- 2025-11-12
- Country
- United States
- Brand
- Elekta
- Product
- Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-02-18
USElekta, 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…
- 2025-02-19
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
FDA · DeviceElekta, Inc.US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina…Official notice → - 2023-12-13
- US
Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator,…
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there…
- 2023-06-14
- US
Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
FDA · DeviceElekta, Inc.US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI,…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-19
- US
Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade. Model Number: 11689304.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting…
FDA · DeviceSiemens Medical Solutions USA, IncUS distribution to California. International distribution to Australia,…Official notice → - 2025-11-12
- US
Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally…
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA,…Official notice → - US
B-K Medical A/S recalls Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general…
FDA · DeviceB-K Medical A/SWorldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
FDA · DeviceTotal Joint Orthopedics, Inc.US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading…
- US
Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot…
FDA · DeviceTandem Diabetes Care, Inc.US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →