Recall Z-0934-2015— Vision Rt Inc
Class II · Terminated
Class II FDA medical device recall by Vision Rt Inc, initiated 2014-11-11, terminated 2016-05-11. It names one FDA 510(k) clearance: K052682. Product: 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.. Reason: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened..
- Recalling firm
- Vision Rt Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-11
- Terminated
- 2016-05-11
- Firm location
- Columbia, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Data sourced from openFDA. This site is unofficial and independent of the FDA.