Z-0934-2015 Class II Terminated
FDA device recall Z-0934-2015 was initiated by Vision Rt Inc on November 11, 2014 and is designated Class II. Reason for recall: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. The recall status is terminated (terminated May 11, 2016). Affected quantity: 55.
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