# FDA recall Z-2535-2018

> **Elekta, Inc.** · Class II · device recall initiated 2018-05-16.

## Product

HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system.      Product Usage:  To support and aid in positioning a patient during radiation therapy

## Reason for recall

Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

## Distribution

Worldwide Distribution - US Distribution of the device was made nationwide.  There was government distribution but no military distribution.      Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Democratic People's Republic of Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Sweden, Thailand, Turkey, United Kingdom, and Viet Nam.

## Key facts

- **Recall number:** Z-2535-2018
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-16
- **Report date:** 2018-08-01
- **Termination date:** 2020-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2018

## Citation

> AI Analytics. FDA recall Z-2535-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2535-2018. Source: US FDA. Licensed CC0.

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