Reported Oct 10, 2018 · Terminated
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based…
Vision RT Ltd.
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 Ltd · Dove House · London · N/A
Is this the product you have?
- 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 numberV000172
- Lot codes and dates
- SoftwareKingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial, MR1, MR2, MR3) V5.0.1749
- Serial numbers
689 of 689 codes
248-010248-013248-016248-021248-022248-030248-038248-041248-042248-048248-054248-063248-064248-069248-070248-071248-072248-076248-080248-083248-084248-085248-087249-0003249-0004249-0005249-0006249-0008249-0009249-0010249-0011249-0012249-0013249-0014249-0015249-0016249-0017249-0018249-0019249-0020249-0021249-0022249-0023249-0024249-0025249-0026249-0027249-0028249-0029249-0030249-0031249-0032249-0033249-0034249-0035249-0036249-0037249-0043249-0045249-0047
- Amount recalled
- 690 systens
Where it was sold
Why it was recalled
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
This product could cause temporary or reversible health problems — stop using it.
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