CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
AlignRT is a video-based three-dimensional recalled by Vision Rt
Vision Rt is recalling AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to, distributed nationwide in the US. The recall was initiated on 11 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0934-2015
- FDA event ID
- 70009
- Recalling firm
- Vision Rt, Columbia, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2014
- FDA classified
- 7 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Nov 2014 | Recall initiated by company | |
| 7 Jan 2015 | Classified by FDA | +57 days |
| 14 Jan 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to recalled?
Yes. Vision Rt recalled AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to on 11 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0934-2015.
Why was it recalled?
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Which lots are affected?
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
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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