Device 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.
Z-0934-2015
Product summary
- Firm
- Vision Rt Inc
- Event
- Event 70009
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55
- Official record key
device-enforcement:Z-0934-2015
Official wording
Reason: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
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
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.