Home / Recalls / Vision Rt Inc / Z-0934-2015

Z-0934-2015 Class II Terminated

Recalled by Vision Rt Inc — Columbia, MD

Recall Details

Product Type
Devices
Report Date
January 14, 2015
Initiation Date
November 11, 2014
Termination Date
May 11, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55

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.

Distribution Pattern

Nationwide Distribution

Code Information

Serial numbers (internally referred to as PCR numbers): USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041 Rest of the world: 247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188

Other recalls by Vision Rt Inc

  • Z-0998-2026 Class II — The AlignRT InBore system contains six Class 1 lasers which enables the system s (August 27, 2025)
  • Z-0065-2019 Class II — Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant on (August 24, 2018)
  • Z-2667-2016 Class II — AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicate (June 30, 2016)
  • Z-2668-2016 Class II — TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K (June 30, 2016)
  • Z-0464-2015 Class II — AlignRT- Intended for prescription use. The system is indicated for use during (October 15, 2014)