Recall Z-0065-2019— Vision RT Ltd

Name: FDA recall Z-0065-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Class II · Terminated

Class II FDA medical device recall by Vision RT Ltd, initiated 2018-08-24, terminated 2022-07-08. It names one FDA 510(k) clearance: K123371. 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: RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB.

Recalling firm: Vision RT Ltd
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Terminated: 2022-07-08
Firm location: London, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K123371 — ALIGNRT PLUSVision RT Limited·cleared 2013-01-08

K-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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.