The Recall Desk
HighFDA (Devices)·Z-0065-2019·Announced 2018-10-10

Vision RT AlignRT Plus Integrated Gate Controller PCB Recall

Vision RT Ltd is recalling 690 AlignRT Plus systems due to an RTInterface error that can occur during I/O communication between the Integrated Gate Controller PCB and the Framegrabber PCB.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential I/O error in a radiotherapy imaging system, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Vision RT Ltd is recalling the Integrated Gate Controller PCB, a component of the AlignRT Plus video-based 3D surface imaging system, specifically for the TrueBeam variant. The recall affects 690 systems distributed nationwide and in multiple foreign countries, including Australia, Canada, China, Germany, Japan, and the United Kingdom.

The recall is being conducted because of an RTInterface error that can occur in the event of an I/O error between the Integrated Gate Controller PCB and the Framegrabber PCB. The AlignRT system is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Specific software versions (Kingsbury V5.0.1747, Wembley Park V5.0.1748, and Neasden V5.0.1749) and a long list of serial numbers are identified in the recall notice.

Healthcare facilities and users should check their equipment serial numbers against the list provided in the official recall notice. If the equipment is affected, users should contact Vision RT Ltd for instructions on corrective actions. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The 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. Part number: V0
Manufacturer
Vision RT Ltd
Category
Medical Device — Radiotherapy Imaging
Hazard
Affected units
690

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Software: Kingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial
  • MR1
  • MR2

Distribution

Distributed nationwide across the United States.

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