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.
Read the official notice →- Date
- 2025-02-19
- Country
- United States
- Brand
- Elekta
- Product
- MOSAIQ Oncology Information System
- Classification
- Class II
- Units
- US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-02-04
USElekta, 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 → - 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 → - 2023-06-07
- US
Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
FDA · DeviceElekta, Inc.Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA.…Official notice →
Other drugs & medical recalls in the United States
- 2025-02-19
- US
Integra LifeSciences Corp. recalls Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A…
Potential that the induction seal is not completely sealed to the device tube packaging.
FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
FDA · DeviceExactech, Inc.U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK,…Official notice → - US
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration…
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Netherlands,…Official notice → - US
HF Acquisition Co LLC recalls Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System,…
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect…
FDA · DeviceHF Acquisition Co LLCUS: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN,…Official notice → - US
Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a…
Device reaching End of Service prematurely.
FDA · DeviceAngel Medical Systems, Inc.US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV,…Official notice → - US
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.