# FDA recall Z-0065-2019

> **Vision RT Ltd** · Class II · device recall initiated 2018-08-24.

## Product

Integrated Gate Controller PCB (component of AlignRT Plus)   Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.     Part number:  V000172

## Reason for recall

RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

## Distribution

Nationwide  Foreign:   Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0065-2019
- **Recalling firm:** Vision RT Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2018-10-10
- **Termination date:** 2022-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** London, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2019

## Citation

> AI Analytics. FDA recall Z-0065-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0065-2019. Source: US FDA. Licensed CC0.

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