Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published March 11, 2019

Brainlab RT Elements Software Recalls: Incorrect Dose Calculation Risk

Brainlab recalls specific RT Elements software versions (1.0.0 and 1.5.0) for cranial, spine, and multiple brain mets SRS applications due to potential incorrect dose distribution calculations when using Pencil Beam algorithm on GPU.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1205-2019Medical deviceBrainlab ›
Take action

Contact the company

Recalling firmBrainlab AGOlof-palme-str. 9 · Munich, Germany
✎ GovInfoNow plain-language explainer

Brainlab is recalling specific versions of their RT Elements software for radiation treatment planning. These versions (1.0.0 and 1.5.0) could cause incorrect dose calculations when using the Pencil Beam algorithm on the default GPU settings, potentially leading to unsafe radiation treatment plans. Read more at govinfonow.com/recall/68858-brainlab-rt-elements-software-recalls-incorrect-dose-calculation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68858-brainlab-rt-elements-software-recalls-incorrect-dose-calculation-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1205-2019

Cite this page

“Brainlab RT Elements Software Recalls: Incorrect Dose Calculation Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68858-brainlab-rt-elements-software-recalls-incorrect-dose-calculation-risk. Based on FDA recall #Z-1205-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2019%22&limit=1).

The FDA announced on March 11, 2019, that Brainlab AG is recalling RT Elements software revisions due to a potential for incorrect dose distribution calculations. The agency stated the hazard arises when using the Pencil Beam algorithm on the GPU under specific circumstances.

How to tell if you have it

  • Brand: Brainlab
  • Product: RT Elements Software (Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA)
  • Versions: 1.0.0 and 1.5.0
  • Model numbers: 21702A, 21702-04C, 21702-06, 21702-12A, 21702-36A, 21702-60A, 21712A, 21722A, 21722-12A, 21741A, 21742, 21742A, 21743, 21743A, 21743-01, 21743-02A, 21743-12, 21743-36, 21743-60, 21744, 21744A, 21744-12, 21744-36, 21744-60, 21745, 21745A, 21747, 21747A, 21748, 21748A, 21748-01, 21748-02A, 21748-12, 21748-36, 21748-60, 21749, 21749A, 21749-12, 21749-36, 21749-60, 21750, 21750A, 21762, 21762A, 21762-01, 21762-02A
  • GTINs: 04056481000554, 704056481140403, 04056481000547, 04056481140380, 704056481006853, 04056481007119, 04056481140397
  • Distribution: Worldwide, including US states AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WV and countries Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom

The hazard

According to the FDA, there is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software under specific circumstances when using the Pencil Beam algorithm on the GPU. This issue occurs as the default system setting.

Context

GovInfoNow's records show Brainlab AG has 15 other recalls on record since July 28, 2017. Recent recalls include Brainlab Origin Data Management Software recalled on Feb. 10, 2025, for patient records merging without notice, and the Brainlab Cirq Arm System 2.0 recalled on March 2, 2023, for mechanical instability risks. Other recent recalls of similar products include RayStation/RayPlan Software Recall from Nov. 28, 2025, and RayStation/RayPlan 10B Software Recall from Nov. 28, 2025.

How to tell if you have this one

Check if your RT Elements software version is Cranial SRS 1.0.0/1.5.0, Spine SRS 1.0.0/1.5.0, Multiple Brain Mets SRS 1.5.0, or RT QA 1.0.0/1.5.0. The software is used for radiation treatment planning in hospitals and clinics.

  • Brand
    Brainlab
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your RT Elements software version by checking the version numbers listed in the recall notice for affected applications.

  2. Update Software

    Install the corrected software version from Brainlab's official website to fix the dose calculation issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 28 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Mar 11, 201912. FDA classified it Class II: Apr 20, 201923. Published in FDA’s Enforcement Report: May 1, 201934. FDA terminated the recall: May 12, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1205-2019 (March 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1205-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA