Reported Jan 14, 2015 · Terminated
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a…
Vision Rt Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vision Rt Inc · 8840 Stanford Blvd · Columbia, MD · 21045-5827
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers (internally
- referred to as PCR numbers)
USA: 247-018247-039247-040247-053247-060247-061247-062247-063247-068247-071247-075247-076247-078247-081247-083247-096247-099247-100247-101247-102247-110247-118247-119247-122247-124247-127247-129247-130247-138247-140247-142247-149247-150247-153247-161247-167247-171247-184247-194247-200247-207247-212247-213248-012248-018248-041
- Rest of the world
247-035247-073247-114247-131247-147247-148247-188
- Amount recalled
- 55
Where it was sold
- Nationwide
Why it was recalled
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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