# FDA recall Z-1205-2019

> **Brainlab AG** · Class II · device recall initiated 2019-03-11.

## Product

RT Elements   Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected:  -	Cranial SRS 1.0.0 and 1.5.0  -	Spine SRS 1.0.0 and 1.5.0  -	Multiple Brain Mets SRS 1.5.0  -       RT QA 1.0.0 and 1.5.0    Product Usage:  The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

## Reason for recall

There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.

## 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, 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.

## Key facts

- **Recall number:** Z-1205-2019
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-11
- **Report date:** 2019-05-01
- **Termination date:** 2021-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2019

## Citation

> AI Analytics. FDA recall Z-1205-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1205-2019. Source: US FDA. Licensed CC0.

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